Hybrid approach of ventricular assist device and autologous bone marrow stem cells implantation in end-stage ischemic heart failure enhances myocardial reperfusion

Directory of Open Access Journals (Sweden)

Khayat Andre

2011-01-01

Full Text Available Abstract We challenge the hypothesis of enhanced myocardial reperfusion after implanting a left ventricular assist device together with bone marrow mononuclear stem cells in patients with end-stage ischemic cardiomyopathy. Irreversible myocardial loss observed in ischemic cardiomyopathy leads to progressive cardiac remodelling and dysfunction through a complex neurohormonal cascade. New generation assist devices promote myocardial recovery only in patients with dilated or peripartum cardiomyopathy. In the setting of diffuse myocardial ischemia not amenable to revascularization, native myocardial recovery has not been observed after implantation of an assist device as destination therapy. The hybrid approach of implanting autologous bone marrow stem cells during assist device implantation may eventually improve native cardiac function, which may be associated with a better prognosis eventually ameliorating the need for subsequent heart transplantation. The aforementioned hypothesis has to be tested with well-designed prospective multicentre studies.

Myocardial fibrosis and pro-fibrotic markers in end-stage heart failure patients during continuous-flow left ventricular assist device support

NARCIS (Netherlands)

Lok, Sjoukje I.; Nous, Fay M. A.; van Kuik, Joyce; van der Weide, Petra; Winkens, Bjorn; Kemperman, Hans; Huisman, Andre; Lahpor, Jaap R; de Weger, Roel A.; de Jonge, Nicolaas

OBJECTIVES: During support with a left ventricular assist device (LVAD), partial reverse remodelling takes place in which fibrosis plays an important role. In this study, we analysed the histological changes and expression of fibrotic markers in patients with advanced heart failure (HF) during

Cerebrovascular accidents in patients with a ventricular assist device.

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Tsukui, Hiroyuki; Abla, Adib; Teuteberg, Jeffrey J; McNamara, Dennis M; Mathier, Michael A; Cadaret, Linda M; Kormos, Robert L

2007-07-01

A cerebrovascular accident is a devastating adverse event in a patient with a ventricular assist device. The goal was to clarify the risk factors for cerebrovascular accident. Prospectively collected data, including medical history, ventricular assist device type, white blood cell count, thrombelastogram, and infection, were reviewed retrospectively in 124 patients. Thirty-one patients (25%) had 48 cerebrovascular accidents. The mean ventricular assist device support period was 228 and 89 days in patients with and without cerebrovascular accidents, respectively (P cerebrovascular accidents occurred within 4 months after implantation. Actuarial freedom from cerebrovascular accident at 6 months was 75%, 64%, 63%, and 33% with the HeartMate device (Thoratec Corp, Pleasanton, Calif), Thoratec biventricular ventricular assist device (Thoratec Corp), Thoratec left ventricular assist device (Thoratec), and Novacor device (WorldHeart, Oakland, Calif), respectively. Twenty cerebrovascular accidents (42%) occurred in patients with infections. The mean white blood cell count at the cerebrovascular accident was greater than the normal range in patients with infection (12,900/mm3) and without infection (9500/mm3). The mean maximum amplitude of the thrombelastogram in the presence of infection (63.6 mm) was higher than that in the absence of infection (60.7 mm) (P = .0309). The risk of cerebrovascular accident increases with a longer ventricular assist device support period. Infection may activate platelet function and predispose the patient to a cerebrovascular accident. An elevation of the white blood cell count may also exacerbate the risk of cerebrovascular accident even in patients without infection. Selection of device type, prevention of infection, and meticulous control of anticoagulation are key to preventing cerebrovascular accident.

Ambient hemolysis and activation of coagulation is different between HeartMate II and HeartWare left ventricular assist devices.

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Birschmann, Ingvild; Dittrich, Marcus; Eller, Thomas; Wiegmann, Bettina; Reininger, Armin J; Budde, Ulrich; Strüber, Martin

2014-01-01

Thromboembolic and bleeding events in patients with a left ventricular assist device (LVAD) are still a major cause of complications. Therefore, the balance between anti-coagulant and pro-coagulant factors needs to be tightly controlled. The principle hypothesis of this study is that different pump designs may have an effect on hemolysis and activation of the coagulation system. Referring to this, the HeartMate II (HMII; Thoratec Corp, Pleasanton, CA) and the HeartWare HVAD (HeartWare International Inc, Framingham, MA) were investigated. For 20 patients with LVAD support (n = 10 each), plasma coagulation, full blood count, and clinical chemistry parameters were measured. Platelet function was monitored using platelet aggregometry, platelet function analyzer-100 system ( Siemens, Marburg, Germany), vasodilator-stimulated phosphoprotein phosphorylation assay, immature platelet fraction, platelet-derived microparticles, and von Willebrand diagnostic. Acquired von Willebrand syndrome could be detected in all patients. Signs of hemolysis, as measured by lactate dehydrogenase levels (mean, 470 U/liter HMII, 250 U/liter HVAD; p < 0.001), were more pronounced in the HMII patients. In contrast, D-dimer analysis indicated a significantly higher activation of the coagulation system in HVAD patients (mean, 0.94 mg/liter HMII, 2.01 mg/liter HVAD; p < 0.01). The efficacy of anti-platelet therapy using clopidogrel was not sufficient in more than 50% of the patients. Our results support the finding that all patients with rotary blood pumps suffered from von Willebrand syndrome. In addition, a distinct footprint of effects on hemolysis and the coagulation system can be attributed to different devices. As a consequence, the individual status of the coagulation system needs to be controlled in long-term patients. © 2013 Published by International Society for the Heart and Lung Transplantation on behalf of International Society for Heart and Lung Transplantation.

Experience With a Long-term Pulsatile Ventricular Assist Device as a Bridge to Heart Transplant in Adults.

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Gómez Bueno, Manuel; Segovia Cubero, Javier; Serrano Fiz, Santiago; Ugarte Basterrechea, Juan; Hernández Pérez, Francisco José; Goirigolzarri Artaza, Josebe; Castedo Mejuto, Evaristo; Burgos Lázaro, Raúl; García Montero, Carlos; Moñivas Palomero, Vanessa; Mingo Santos, Susana; González Román, Ana Isabel; Álvarez Avelló, José Manuel; Vidal Fernández, Mercedes; Forteza Gil, Alberto; Alonso-Pulpón, Luis

2017-09-01

Most long-term ventricular assist devices (VADs) that are currently implanted are intracorporeal continuous-flow devices. Their main limitations include their high cost and inability to provide biventricular support. The aim of this study was to describe the results of using paracorporeal pulsatile-flow VADs as a bridge to transplant (BTT) in adult patients. Retrospective analysis of the characteristics, complications, and outcomes of a single-center case series of consecutive patients treated with the EXCOR VAD as BTT between 2009 and 2015. During the study period, 25 VADs were implanted, 6 of them biventricular. Ventricular assist devices were indicated directly as a BTT in 12 patients and as a bridge to decision in 13 due to the presence of potentially reversible contraindications or chance of heart function recovery. Twenty patients (80%) were successfully bridged to heart transplant after a median of 112 days (range, 8-239). The main complications included infectious (52% of patients), neurological events (32%, half of them fatal), bleeding (28%), and VAD malfunction requiring component replacement (28%). Eighty percent of patients with the EXCOR VAD as BTT achieved the goal after an average of almost 4 months of support. The most frequent complications were infectious, and the most severe were neurological. In our enivonment, the use of these pulsatile-flow VAD as BTT is a feasible strategy that obtains similar outcomes to those of intracorporeal continuous-flow devices. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Beneficial aspects of real time flow measurements for the management of acute right ventricular heart failure following continuous flow ventricular assist device implantation

Directory of Open Access Journals (Sweden)

Spiliopoulos Sotirios

2012-11-01

Full Text Available Abstract Background Optimal management of acute right heart failure following the implantation of a left ventricular assist device requires a reliable estimation of left ventricular preload and contractility. This is possible by real-time pump blood flow measurements. Clinical case We performed implantation of a continuous flow left ventricular assist device in a 66 years old female patient with an end-stage heart failure on the grounds of a dilated cardiomyopathy. Real-time pump blood flow was directly measured by an ultrasonic flow probe placed around the outflow graft. Diagnosis The progressive decline of real time flow and the loss of pulsatility were associated with an increase of central venous pressure, inotropic therapy and progressive renal failure suggesting the presence of an acute right heart failure. Diagnosis was validated by echocardiography and thermodilution measurements. Treatment Temporary mechanical circulatory support of the right ventricle was successfully performed. Real time flow measurement proved to be a useful tool for the diagnosis and ultimately for the management of right heart failure including the weaning from extracorporeal membrane oxygenation.

Endocarditis in left ventricular assist device

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Thyagarajan, Braghadheeswar; Kumar, Monisha Priyadarshini; Sikachi, Rutuja R; Agrawal, Abhinav

2016-01-01

Summary Heart failure is one of the leading causes of death in developed nations. End stage heart failure often requires cardiac transplantation for survival. The left ventricular assist device (LVAD) has been one of the biggest evolvements in heart failure management often serving as bridge to transplant or destination therapy in advanced heart failure. Like any other medical device, LVAD is associated with complications with infections being reported in many patients. Endocarditis developing secondary to the placement of LVAD is not a frequent, serious and difficult to treat condition with high morbidity and mortality. Currently, there are few retrospective studies and case reports reporting the same. In our review, we found the most common cause of endocarditis in LVAD was due to bacteria. Both bacterial and fungal endocarditis were associated with high morbidity and mortality. In this review we will be discussing the risk factors, organisms involved, diagnostic tests, management strategies, complications, and outcomes in patients who developed endocarditis secondary to LVAD placement. PMID:27672540

Ramp Study Hemodynamics, Functional Capacity, and Outcome in Heart Failure Patients with Continuous-Flow Left Ventricular Assist Devices

DEFF Research Database (Denmark)

Jung, Mette H; Gustafsson, Finn; Houston, Brian

2016-01-01

Ramp studies-measuring changes in cardiac parameters as a function of serial pump speed changes (revolutions per minute [rpm])-are increasingly used to evaluate function and malfunction of continuous-flow left ventricular assist devices (CF-LVADs). We hypothesized that ramp studies can predict...... patients (HeartMate II, Thoratec Corporation, Pleasanton, CA). Functional status was evaluated in 70% (31/44); average 6 minute walk test (6MWT) was 312 ± 220 min, New York Heart Association (NYHA) I-II/III-IV (70/30%) and activity scores very low-low/moderate-very high (55/45%). Decrease in pulmonary...

Left Ventricular Assist Devices: The Adolescence of a Disruptive Technology.

Science.gov (United States)

Pinney, Sean P

2015-10-01

Clinical outcomes for patients with advanced heart failure receiving left ventricular assist devices are driven by appropriate patient selection, refined surgical technique, and coordinated medical care. Perhaps even more important is innovative pump design. The introduction and widespread adoption of continuous-flow ventricular assist devices has led to a paradigm shift within the field of mechanical circulatory support, making the promise of lifetime device therapy closer to reality. The disruption caused by this new technology, on the one hand, produced meaningful improvements in patient survival and quality of life, but also introduced new clinical challenges, such as bleeding, pump thrombosis, and acquired valvular heart disease. Further evolution within this field will require financial investment to sustain innovation leading to a fully implantable, durable, and cost-effective pump for a larger segment of patients with advanced heart failure. Copyright © 2015 Elsevier Inc. All rights reserved.

Reduced Anxiety and Depression in Patients With Advanced Heart Failure After Left Ventricular Assist Device Implantation.

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Yost, Gardner; Bhat, Geetha; Mahoney, Edward; Tatooles, Antone

Despite the high prevalence of depression and anxiety in patients with advanced heart failure, the effects of left ventricular assist device (LVAD) implantation on these critically important aspects of mental health are not well understood. We sought to assess changes in depression and anxiety following LVAD implantation. The Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI) were administered to 54 patients by a clinical psychologist at a mean of 12 days before LVAD implantation and 251 days after implantation. Patient demographics and clinical data were collected concurrently to psychologic testing. Changes in BDI-II, BAI, and clinical markers of heart failure were assessed using paired t-tests. A p Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

Comparison of Transplant Waitlist Outcomes for Pediatric Candidates Supported by Ventricular Assist Devices Versus Medical Therapy.

Science.gov (United States)

Law, Sabrina P; Oron, Assaf P; Kemna, Mariska S; Albers, Erin L; McMullan, D Michael; Chen, Jonathan M; Law, Yuk M

2018-05-01

Ventricular assist devices have gained popularity in the management of refractory heart failure in children listed for heart transplantation. Our primary aim was to compare the composite endpoint of all-cause pretransplant mortality and loss of transplant eligibility in children who were treated with a ventricular assist device versus a medically managed cohort. This was a retrospective cohort analysis. Data were obtained from the Scientific Registry of Transplant Recipients. The at-risk population (n = 1,380) was less than 18 years old, either on a ventricular assist device (605 cases) or an equivalent-severity, intensively medically treated group (referred to as MED, 775 cases). None. The impact of ventricular assist devices was estimated via Cox proportional hazards regression (hazard ratio), dichotomizing 1-year outcomes to "poor" (22%: 193 deaths, 114 too sick) versus all others (940 successful transplants, 41 too healthy, 90 censored), while adjusting for conventional risk factors. Among children 0-12 months old, ventricular assist device was associated with a higher risk of poor outcomes (hazard ratio, 2.1; 95% CI, 1.5-3.0; p comparative study of ventricular assist devices versus medical therapy in children. Age is a significant modulator of waitlist outcomes for children with end-stage heart failure supported by ventricular assist device, with the impact of ventricular assist devices being more beneficial in adolescents.

Ethical Analysis of Withdrawing Ventricular Assist Device Support

OpenAIRE

Mueller, Paul S.; Swetz, Keith M.; Freeman, Monica R.; Carter, Kari A.; Crowley, Mary Eliot; Severson, Cathy J. Anderson; Park, Soon J.; Sulmasy, Daniel P.

2010-01-01

OBJECTIVE: To describe a series of patients with heart failure supported with a ventricular assist device (VAD) who requested (or whose surrogates requested) withdrawal of VAD support and the legal and ethical aspects pertaining to these requests.

The medical physics of ventricular assist devices

International Nuclear Information System (INIS)

Wood, Houston G; Throckmorton, Amy L; Untaroiu, Alexandrina; Song Xinwei

2005-01-01

Millions of patients, from infants to adults, are diagnosed with congestive heart failure each year all over the world. A limited number of donor hearts available for these patients results in a tremendous demand for alternative, supplemental circulatory support in the form of artificial heart pumps or ventricular assist devices (VADs). The development procedure for such a device requires careful consideration of biophysical factors, such as biocompatibility, haemolysis, thrombosis, implantability, physiologic control feasibility and pump performance. Conventional pump design equations based on Newton's law and computational fluid dynamics (CFD) are readily used for the initial design of VADs. In particular, CFD can be employed to predict the pressure-flow performance, hydraulic efficiencies, flow profile through the pump, stress levels and biophysical factors, such as possible blood cell damage. These computational flow simulations may involve comprehensive steady and transient flow analyses. The transient simulations involve time-varying boundary conditions and virtual modelling of the impeller rotation in the blood pumps. After prototype manufacture, laser flow measurements with sophisticated optics and mock circulatory flow loop testing assist with validation of pump design and identification of irregular flow patterns for optimization. Additionally, acute and chronic animal implants illustrate the blood pump's ability to support life physiologically. These extensive design techniques, coupled with fundamental principles of physics, ensure a reliable and effective VAD for thousands of heart failure patients each year

Risk Stratification of Patients With Current Generation Continuous-Flow Left Ventricular Assist Devices Being Bridged to Heart Transplantation.

Science.gov (United States)

Guha, Ashrith; Nguyen, Duc; Cruz-Solbes, Ana S; Amione-Guerra, Javier; Schutt, Robert C; Bhimaraj, Arvind; Trachtenberg, Barry H; Park, Myung H; Graviss, Edward A; Gaber, Osama; Suarez, Erik; Montane, Eva; Torre-Amione, Guillermo; Estep, Jerry D

Patients bridged to transplant (BTT) with continuous-flow left ventricular assist devices (CF-LVADs) have increased in the past decade. Decision support tools for these patients are limited. We developed a risk score to estimate prognosis and guide decision-making. We included heart transplant recipients bridged with CF-LVADs from the United Network for Organ Sharing (UNOS) database and divided them into development (2,522 patients) and validation cohorts (1,681 patients). Univariate and multivariate Cox proportional hazards models were performed. Variables that independently predicted outcomes (age, African American race, recipient body mass index [BMI], intravenous [IV] antibiotic use, pretransplant dialysis, and total bilirubin) were assigned weight using linear transformation, and risk scores were derived. Patients were grouped by predicted posttransplant mortality: low risk (≤ 38 points), medium risk (38-41 points), and high risk (≥ 42 points). We performed Cox proportional hazards analysis on wait-listed CF-LVAD patients who were not transplanted. Score significantly discriminated survival among the groups in the development cohort (6.7, 12.9, 20.7; p = 0.001), validation cohort (6.4, 10.1, 13.6; p assist device (LVAD) BTT risk score that effectively identifies CF-LVAD patients who are at higher risk for worse outcomes after heart transplant. This score may help physicians weigh the risks of transplantation in patients with CF-LVAD.

Current Trends in Implantable Left Ventricular Assist Devices

Directory of Open Access Journals (Sweden)

Jens Garbade

2011-01-01

Full Text Available The shortage of appropriate donor organs and the expanding pool of patients waiting for heart transplantation have led to growing interest in alternative strategies, particularly in mechanical circulatory support. Improved results and the increased applicability and durability with left ventricular assist devices (LVADs have enhanced this treatment option available for end-stage heart failure patients. Moreover, outcome with newer pumps have evolved to destination therapy for such patients. Currently, results using nonpulsatile continuous flow pumps document the evolution in outcomes following destination therapy achieved subsequent to the landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure Trial (REMATCH, as well as the outcome of pulsatile designed second-generation LVADs. This review describes the currently available types of LVADs, their clinical use and outcomes, and focuses on the patient selection process.

COST-EFFECTIVENESS OF CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICES

NARCIS (Netherlands)

Neyt, Mattias; Van den Bruel, Ann; Smit, Yolba; De Jonge, Nicolaas; Erasmus, Michiel; Van Dijk, Diederik; Vlayen, Joan

Objectives: Mechanical circulatory support through left ventricular assist devices (LVADs) improves survival and quality of life for patients with end-stage heart failure who are ineligible for cardiac transplantation. Our aim was to calculate the cost-effectiveness of continuous-flow LVADs.

Left ventricular assist device as destination therapy: application of the payment-by-results approach for the device reimbursement.

Science.gov (United States)

Messori, Andrea; Trippoli, Sabrina; Bonacchi, Massimo; Sani, Guido

2009-08-01

Value-based methods are increasingly used to reimburse therapeutic innovation, and the payment-by-results approach has been proposed for handling interventions with limited therapeutic evidence. Because most left ventricular assist devices are supported by preliminary efficacy data, we examined the effectiveness data of the HeartMate (Thoratec Corp, Pleasanton, CA) device to explore the application of the payment-by-results approach to these devices and to develop a model for handling reimbursements. According to our model, after establishing the societal economic countervalue for each month of life saved, each patient treated with one such device is associated to the payment of this countervalue for every month of survival lived beyond the final date of estimated life expectancy without left ventricular assist devices. Our base-case analysis, which used the published data of 68 patients who received the HeartMate device, was run with a monthly countervalue of euro 5000, no adjustment for quality of life, and a baseline life expectancy of 150 days without left ventricular assist devices. Sensitivity analysis was aimed at testing the effect of quality of life adjustments and changes in life expectancy without device. In our base-case analysis, the mean total reimbursement per patient was euro 82,426 (range, euro 0 to euro 250,000; N = 68) generated as the sum of monthly payments. This average value was close to the current price of the HeartMate device (euro 75,000). Sensitivity testing showed that the base-case reimbursement of euro 82,426 was little influenced by variations in life expectancy, whereas variations in utility had a more pronounced impact. Our report delineates an innovative procedure for appropriately allocating economic resources in this area of invasive cardiology.

Understanding the C-pulse device and its potential to treat heart failure.

Science.gov (United States)

Sales, Virna L; McCarthy, Patrick M

2010-03-01

The Sunshine Heart C-Pulse (C-Pulse; Sunshine Heart Inc., Tustin, CA) device is an extra-aortic implantable counterpulsation pump designed as a non-blood contacting ambulatory heart assist device, which may provide relief from symptoms for class II-III congestive heart failure patients. It has a comparable hemodynamic augmentation to intra-aortic balloon counterpulsation devices. The C-Pulse cuff is implanted through a median sternotomy, secured around the ascending aorta, and pneumatically driven by an external system controller. Pre-clinical studies in the acute pig model, and initial temporary clinical studies in patients undergoing off-pump coronary bypass surgery have shown substantial increase in diastolic perfusion of the coronary vessels, which translated to a favorable improvement in ventricular function. A U.S. prospective multi-center trial to evaluate the safety and efficacy of the C-Pulse in class III patients with moderate heart failure is now in progress.

Personal digital assistant-based, internet-enabled remote communication system for a wearable pneumatic biventricular assist device.

Science.gov (United States)

Nam, Kyoung Won; Lee, Jung Joo; Hwang, Chang Mo; Choi, Seong Wook; Son, Ho Sung; Sun, Kyung

2007-11-01

Currently, personal mobile communication devices have become quite common, and the applications of such devices have expanded quickly. Remote communication systems might be employed for the telemonitoring of patients or the operating status of their medical devices. In this article, we describe the development of a mobile-based artificial heart telemanagement system for use in a wearable extracorporeal pneumatic biventricular assist device, which is capable of telemonitoring and telecontrolling the operating status of the ventricular assist device from any site. The system developed herein utilized small mobile phones for the client device and adopted a standard transmission control protocol/Internet protocol communication protocol for the purposes of telecommunication. The results of in vitro and animal experiments showed that the telemanagement system developed herein operated in accordance with the desired parameters.

Developments in control systems for rotary left ventricular assist devices for heart failure patients: a review.

Science.gov (United States)

AlOmari, Abdul-Hakeem H; Savkin, Andrey V; Stevens, Michael; Mason, David G; Timms, Daniel L; Salamonsen, Robert F; Lovell, Nigel H

2013-01-01

From the moment of creation to the moment of death, the heart works tirelessly to circulate blood, being a critical organ to sustain life. As a non-stopping pumping machine, it operates continuously to pump blood through our bodies to supply all cells with oxygen and necessary nutrients. When the heart fails, the supplement of blood to the body's organs to meet metabolic demands will deteriorate. The treatment of the participating causes is the ideal approach to treat heart failure (HF). As this often cannot be done effectively, the medical management of HF is a difficult challenge. Implantable rotary blood pumps (IRBPs) have the potential to become a viable long-term treatment option for bridging to heart transplantation or destination therapy. This increases the potential for the patients to leave the hospital and resume normal lives. Control of IRBPs is one of the most important design goals in providing long-term alternative treatment for HF patients. Over the years, many control algorithms including invasive and non-invasive techniques have been developed in the hope of physiologically and adaptively controlling left ventricular assist devices and thus avoiding such undesired pumping states as left ventricular collapse caused by suction. In this paper, we aim to provide a comprehensive review of the developments of control systems and techniques that have been applied to control IRBPs.

Developments in control systems for rotary left ventricular assist devices for heart failure patients: a review

International Nuclear Information System (INIS)

AlOmari, Abdul-Hakeem H; Savkin, Andrey V; Lovell, Nigel H; Stevens, Michael; Mason, David G; Timms, Daniel L; Salamonsen, Robert F

2013-01-01

From the moment of creation to the moment of death, the heart works tirelessly to circulate blood, being a critical organ to sustain life. As a non-stopping pumping machine, it operates continuously to pump blood through our bodies to supply all cells with oxygen and necessary nutrients. When the heart fails, the supplement of blood to the body's organs to meet metabolic demands will deteriorate. The treatment of the participating causes is the ideal approach to treat heart failure (HF). As this often cannot be done effectively, the medical management of HF is a difficult challenge. Implantable rotary blood pumps (IRBPs) have the potential to become a viable long-term treatment option for bridging to heart transplantation or destination therapy. This increases the potential for the patients to leave the hospital and resume normal lives. Control of IRBPs is one of the most important design goals in providing long-term alternative treatment for HF patients. Over the years, many control algorithms including invasive and non-invasive techniques have been developed in the hope of physiologically and adaptively controlling left ventricular assist devices and thus avoiding such undesired pumping states as left ventricular collapse caused by suction. In this paper, we aim to provide a comprehensive review of the developments of control systems and techniques that have been applied to control IRBPs. (topical review)

Performance of Noninvasive Assessment in the Diagnosis of Right Heart Failure After Left Ventricular Assist Device.

Science.gov (United States)

Joly, Joanna M; El-Dabh, Ashraf; Marshell, Ramey; Chatterjee, Arka; Smith, Michelle G; Tresler, Margaret; Kirklin, James K; Acharya, Deepak; Rajapreyar, Indranee N; Tallaj, José A; Pamboukian, Salpy V

2018-06-01

Right heart failure (RHF) after left ventricular assist device (LVAD) is associated with poor outcomes. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) defines RHF as elevated right atrial pressure (RAP) plus venous congestion. The purpose of this study was to examine the diagnostic performance of the noninvasive INTERMACS criteria using RAP as the gold standard. We analyzed 108 patients with LVAD who underwent 341 right heart catheterizations (RHC) between January 1, 2006, and December 31, 2013. Physical exam, echocardiography, and laboratory data at the time of RHC were collected. Conventional two-by-two tables were used and missing data were excluded. The noninvasive INTERMACS definition of RHF is 32% sensitive (95% CI, 0.21-0.44) and 97% specific (95% CI, 0.95-0.99) for identifying elevated RAP. Clinical assessment failed to identify two-thirds of LVAD patients with RAP > 16 mm Hg. More than half of patients with elevated RAP did not have venous congestion, which may represent a physiologic opportunity to mitigate the progression of disease before end-organ damage occurs. One-quarter of patients who met the noninvasive definition of RHF did not actually have elevated RAP, potentially exposing patients to unnecessary therapies. In practice, if any component of the INTERMACS definition is present or equivocal, our data suggest RHC is warranted to establish the diagnosis.

Ventricular assist device implantation in a young patient with non-compaction cardiomyopathy and hereditary spherocytosis.

Science.gov (United States)

Huenges, Katharina; Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-04-01

A case of a 15-year-old female patient with acute heart failure due to non-compaction cardiomyopathy and hereditary anaemia (hereditary spherocytic elliptocytosis) requiring ventricular assist device implantation as a bridge to transplantation is presented. The possible effects of mechanical stress on erythrocytes potentially induced by mechanical circulatory support remains unclear, but it may lead to haemolytic crisis in patients suffering from hereditary anaemia. In our case, ventricular assist device therapy was feasible, and haematological complications did not occur within 6 weeks of bridging our patient to heart transplantation.

Exercise physiology with a left ventricular assist device: Analysis of heart-pump interaction with a computational simulator.

Science.gov (United States)

Fresiello, Libera; Rademakers, Frank; Claus, Piet; Ferrari, Gianfranco; Di Molfetta, Arianna; Meyns, Bart

2017-01-01

Patients with a Ventricular Assist Device (VAD) are hemodynamically stable but show an impaired exercise capacity. Aim of this work is to identify and to describe the limiting factors of exercise physiology with a VAD. We searched for data concerning exercise in heart failure condition and after VAD implantation from the literature. Data were analyzed by using a cardiorespiratory simulator that worked as a collector of inputs coming from different papers. As a preliminary step the simulator was used to reproduce the evolution of hemodynamics from rest to peak exercise (ergometer cycling) in heart failure condition. Results evidence an increase of cardiac output of +2.8 l/min and a heart rate increase to 67% of the expected value. Then, we simulated the effect of a continuous-flow VAD at both rest and exercise. Total cardiac output increases of +3.0 l/min (+0.9 l/min due to the VAD and +2.1 l/min to the native ventricle). Since the left ventricle works in a non-linear portion of the diastolic stiffness line, we observed a consistent increase of pulmonary capillary wedge pressure (from 14 to 20 mmHg) for a relatively small increase of end-diastolic volume (from 182 to 189 cm3). We finally increased VAD speed during exercise to the maximum possible value and we observed a reduction of wedge pressure (-4.5 mmHg), a slight improvement of cardiac output (8.0 l/min) and a complete unloading of the native ventricle. The VAD can assure a proper hemodynamics at rest, but provides an insufficient unloading of the left ventricle and does not prevent wedge pressure from rising during exercise. Neither the VAD provides major benefits during exercise in terms of total cardiac output, which increases to a similar extend to an unassisted heart failure condition. VAD speed modulation can contribute to better unload the ventricle but the maximal flow reachable with the current devices is below the cardiac output observed in a healthy heart.

Improving hemodynamics of cardiovascular system under a novel intraventricular assist device support via modeling and simulations.

Science.gov (United States)

Zhu, Shidong; Luo, Lin; Yang, Bibo; Li, Xinghui; Wang, Xiaohao

2017-12-01

Ventricular assist devices (LVADs) are increasingly recognized for supporting blood circulation in heart failure patients who are non-transplant eligible. Because of its volume, the traditional pulsatile device is not easy to implant intracorporeally. Continuous flow LVADs (CF-LVADs) reduce arterial pulsatility and only offer continuous flow, which is different from physiological flow, and may cause long-term complications in the cardiovascular system. The aim of this study was to design a new pulsatile assist device that overcomes this disadvantage, and to test this device in the cardiovascular system. Firstly, the input and output characteristics of the new device were tested in a simple cardiovascular mock system. A detailed mathematical model was established by fitting the experimental data. Secondly, the model was tested in four pathological cases, and was simulated and coupled with a fifth-order cardiovascular system and a new device model using Matlab software. Using assistance of the new device, we demonstrated that the left ventricle pressure, aortic pressure, and aortic flow of heart failure patients improved to the levels of a healthy individual. Especially, in state IV level heart failure patients, the systolic blood pressure increased from 81.34 mmHg to 132.1 mmHg, whereas the diastolic blood pressure increased from 54.28 mmHg to 78.7 mmHg. Cardiac output increased from 3.21 L/min to 5.16 L/min. The newly-developed assist device not only provided a physiological flow that was similar to healthy individuals, but also effectively improved the ability of the pathological ventricular volume. Finally, the effects of the new device on other hemodynamic parameters are discussed.

The role of cerebral hyperperfusion in postoperative neurologic dysfunction after left ventricular assist device implantation for end-stage heart failure.

Science.gov (United States)

Lietz, Katherine; Brown, Kevin; Ali, Syed S; Colvin-Adams, Monica; Boyle, Andrew J; Anderson, David; Weinberg, Alan D; Miller, Leslie W; Park, Soon; John, Ranjit; Lazar, Ronald M

2009-04-01

Cerebral hyperperfusion is a life-threatening syndrome that can occur in patients with chronically hypoperfused cerebral vasculature whose normal cerebral circulation was re-established after carotid endarterectomy or angioplasty. We sought to determine whether the abrupt restoration of perfusion to the brain after left ventricular assist device (LVAD) implantation produced similar syndromes. We studied the role of increased systemic flow after LVAD implantation on neurologic dysfunction in 69 consecutive HeartMate XVE LVAD (Thoratec, Pleasanton, Calif) recipients from October 2001 through June 2006. Neurologic dysfunction was defined as postoperative permanent or transient central change in neurologic status, including confusion, focal neurologic deficits, visual changes, seizures, or coma for more than 24 hours within 30 days after LVAD implantation. We found that 19 (27.5%) patients had neurologic dysfunction, including encephalopathy (n = 11), coma (n = 3), and other complications (n = 5). The multivariate analysis showed that an increase in cardiac index from the preoperative baseline value (relative risk, 1.33 per 25% cardiac index increase; P = .01) and a previous coronary bypass operation (relative risk, 4.53; P = .02) were the only independent predictors of neurologic dysfunction. Reduction of left ventricular assist device flow in 16 of the 19 symptomatic patients led to improvement of symptoms in 14 (87%) patients. Our findings showed that normal flow might overwhelm cerebral autoregulation in patients with severe heart failure, suggesting that cerebral hyperperfusion is possible in recipients of mechanical circulatory support with neurologic dysfunction.

Management of single-ventricle patients with Berlin Heart EXCOR Ventricular Assist Device: single-center experience.

Science.gov (United States)

Mackling, Tracey; Shah, Tejas; Dimas, Vivian; Guleserian, Kristine; Sharma, Mahesh; Forbess, Joseph; Ardura, Monica; Gross-Toalson, Jami; Lee, Ying; Journeycake, Janna; Barnes, Aliessa

2012-06-01

There are minimal data regarding chronic management of single-ventricle ventricular assist device (VAD) patients. This study aims to describe our center's multidisciplinary team management of single-ventricle patients supported long term with the Berlin Heart EXCOR Pediatric VAD. Patient #1 was a 4-year-old with double-outlet right ventricle with aortic atresia, L-looped ventricles, and heart block who developed heart failure 1 year after Fontan. She initially required extracorporeal membrane oxygenation support and was transitioned to Berlin Heart systemic VAD. She was supported for 363 days (cardiac intensive care unit [CICU] 335 days, floor 28 days). The postoperative course was complicated by intermittent infection including methicillin-resistant Staphylococcus aureus, intermittent hepatic and renal insufficiencies, and transient antithrombin, protein C, and protein S deficiencies resulting in multiple thrombi. She had a total of five pump changes over 10 months. Long-term medical management included anticoagulation with enoxaparin, platelet inhibition with aspirin and dipyridamole, and antibiotic prophylaxis using trimethoprim/sulfamethoxazole. She developed sepsis of unknown etiology and subsequently died from multiorgan failure. Patient #2 was a 4-year-old with hypoplastic left heart syndrome who developed heart failure 2 years after bidirectional Glenn shunt. At systemic VAD implantation, he was intubated with renal insufficiency. Post-VAD implantation, his renal insufficiency resolved, and he was successfully extubated to daytime nasal cannula and biphasic positive airway pressure at night. He was supported for 270 days (CICU 143 days, floor 127 days). The pump was upsized to a 50-mL pump in May 2011 for increased central venous pressures (29 mm Hg). Long-term medical management included anticoagulation with warfarin and single-agent platelet inhibition using dipyridamole due to aspirin resistance. He developed increased work of breathing requiring

Impact of Vice President Cheney on public interest in left ventricular assist devices and heart transplantation.

Science.gov (United States)

Pandey, Ambarish; Abdullah, Kazeen; Drazner, Mark H

2014-05-01

Although celebrity illnesses attract a significant amount of media attention in the United States, there are few studies that have looked at how celebrity health conditions impact the awareness of the illness in the general population. Recently, Vice President Cheney underwent left ventricular assist device (LVAD) implantation and subsequently a cardiac transplant. The aim of this study was to determine whether there was evidence of increased interest in these 2 procedures as assessed by social media. We determined the relative frequency of Google searches for LVAD and heart transplantation from 2004 to 2013 using Google trends. We also counted the number of YouTube videos and Twitter messages posted monthly concerning LVADs over a 7-year time frame. There was a significant spike in the Google search interest for LVAD and heart transplantation in the month when Vice President Cheney underwent the respective procedure. Similarly, there was a large increase in YouTube videos and Twitter messages concerning LVADs shortly after he was implanted. In total, these data support the concept that a public figure's illness can significantly influence the public's interest in that condition and its associated therapies. Copyright © 2014 Elsevier Inc. All rights reserved.

Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes.

Science.gov (United States)

Zimpfer, Daniel; Netuka, Ivan; Schmitto, Jan D; Pya, Yuriy; Garbade, Jens; Morshuis, Michiel; Beyersdorf, Friedhelm; Marasco, Silvana; Rao, Vivek; Damme, Laura; Sood, Poornima; Krabatsch, Thomas

2016-09-01

The objective of this study was to describe the operative experience and 30-day outcomes of patients implanted with the HeartMate 3 Left Ventricular Assist System (LVAS) during the Conformité Européenne (CE) Mark clinical trial. Adult patients met inclusion and exclusion criteria defining advanced-stage heart failure and included the indications of bridge to transplant and destination therapy. Operative parameters, outcomes, adverse events, physical status and quality-of-life parameters were assessed in the first 30 days after LVAS implant. Fifty patients were implanted with the HeartMate 3 at 10 centres in 6 countries. The 30-day survival rate was 98%. The median operative and cardiopulmonary bypass times were 200 (range: 95-585) min and 84 (range: 47-250) min, respectively. Patients required transfusion with packed red blood cells (3.6 ± 2.3 units), fresh frozen plasma (6.5 ± 5 units) and platelets (2 ± 1 units). Six patients (12%) required reoperation for postoperative bleeding and 10 patients (20%) did not require blood transfusion. The median intensive care time was 6 days (range: 1-112 days) and the total hospital stay was 28 days (range: 14-116 days). The most common adverse events were bleeding (15, 30%), arrhythmia (14, 28%) and infection (10, 20%). There were 2 (4%) strokes. The 30-day outcomes following implantation of the HeartMate 3 demonstrates excellent survival with low adverse event rates. The LVAD performed as intended with no haemolysis or device failure. NCT02170363. HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark). © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Usefulness of Tricuspid Annular Diameter to Predict Late Right Sided Heart Failure in Patients With Left Ventricular Assist Device.

Science.gov (United States)

Nakanishi, Koki; Homma, Shunichi; Han, Jiho; Takayama, Hiroo; Colombo, Paolo C; Yuzefpolskaya, Melana; Garan, Arthur R; Farr, Maryjane A; Kurlansky, Paul; Di Tullio, Marco R; Naka, Yoshifumi; Takeda, Koji

2018-07-01

Although late-onset right-sided heart failure is recognized as a clinical problem in the treatment of patients with left ventricular assist devices (LVADs), the mechanism and predictors are unknown. Tricuspid valve (TV) deformation leads to the restriction of the leaflet motion and decreased coaptation, resulting in a functional tricuspid regurgitation that may act as a surrogate marker of late right-sided heart failure. This study aimed to investigate the association of preoperative TV deformation (annulus dilatation and leaflet tethering) with late right-sided heart failure development after continuous-flow LVAD implantation. The study cohort consisted of 274 patients who underwent 2-dimensional echocardiography before LVAD implantation. TV annulus diameter and tethering distance were measured in an apical 4-chamber view. Late right-sided heart failure was defined as right-sided heart failure requiring readmission and medical and/or surgical treatment after initial LVAD implantation. During a mean follow-up of 25.1 ± 19.0 months after LVAD implantation, late right-sided heart failure occurred in 33 patients (12.0%). Multivariate Cox proportional hazard analysis demonstrated that TV annulus diameter (hazard ratio 1.221 per 1 mm, p right-sided heart failure development, whereas leaflet tethering distance was not. The best cut-off value of the TV annular diameter was 41 mm (area under the curve 0.787). Kaplan-Meier analysis showed that patients with dilated TV annulus (TV annular diameter ≥41 mm) exhibited a significantly higher late right-sided heart failure occurrence than those without TV annular enlargement (log-rank p right-sided heart failure after LVAD implantation. Copyright © 2018 Elsevier Inc. All rights reserved.

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement.

Science.gov (United States)

Huenges, Katharina; Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-01-01

Left ventricular assist device (LVAD) is nowadays a routine therapy for patients with advanced heart failure. We present the case of a 74-year-old male patient who was admitted to our center with terminal heart failure in dilated cardiomyopathy and ascending aortic aneurysm with aortic valve regurgitation. The LVAD implantation with simultaneous aortic valve and supracoronary ascending aortic replacement was successfully performed.

Surgical treatment of tricuspid valve insufficiency promotes early reverse remodeling in patients with axial-flow left ventricular assist devices.

Science.gov (United States)

Maltais, Simon; Topilsky, Yan; Tchantchaleishvili, Vakhtang; McKellar, Stephen H; Durham, Lucian A; Joyce, Lyle D; Daly, Richard C; Park, Soon J

2012-06-01

The HeartMate II (Thoratec Corp, Pleasanton, Calif) continuous-flow left ventricular assist device has emerged as the standard of care for patients with advanced heart failure. The objective of this study was to assess the safety and early effectiveness of concomitant tricuspid valve procedures in patients undergoing implantation of a HeartMate II device. From February 2007 to April 2010, 83 patients underwent HeartMate II left ventricular assist device implantation. Of these, 37 patients had concomitant tricuspid valve procedures (32 repairs, 5 replacements) for severe tricuspid regurgitation. The effects of a tricuspid valve procedure on tricuspid regurgitation and right ventricular remodeling were assessed comparing echocardiographic findings at baseline and 30 days after left ventricular assist device implantation. Overall survival was also compared. Patients undergoing a concomitant tricuspid valve procedure had more tricuspid regurgitation (vena contracta, 5.6 ± 2.1 mm vs 2.9 ± 2.0 mm; P tricuspid regurgitation was worse in patients who underwent left ventricular assist device implantation alone (+18.6%), whereas it improved significantly in patients undergoing a concomitant tricuspid valve procedure (-50.2%) (P = .005). A corresponding significant reduction in right ventricular end-diastolic area (33.6% ± 6.2% vs 30.1% ± 9.7%; P = .03) and a trend toward better right ventricular function (55.5% ± 79.7% vs 35.7% ± 60.5%; P = .28) were noted in patients undergoing a concomitant tricuspid valve procedure. Survival was comparable between the 2 groups. In patients with severe tricuspid regurgitation undergoing left ventricular assist device implantation, a concomitant tricuspid valve procedure effectively reduces tricuspid regurgitation and promotes reverse remodeling of the right ventricle. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Impact of ventricular assist device placement on longitudinal renal function in children with end-stage heart failure.

Science.gov (United States)

May, Lindsay J; Montez-Rath, Maria E; Yeh, Justin; Axelrod, David M; Chen, Sharon; Maeda, Katsuhide; Almond, Christopher S D; Rosenthal, David N; Hollander, Seth A; Sutherland, Scott M

2016-04-01

Although ventricular assist devices (VADs) restore hemodynamics in those with heart failure, reversibility of end-organ dysfunction with VAD support is not well characterized. Renal function often improves in adults after VAD placement, but this has not been comprehensively explored in children. Sixty-three children on VAD support were studied. Acute kidney injury (AKI) was defined by Kidney Disease: Improving Global Outcomes criteria. Estimated glomerular filtration rate (eGFR) was determined by the Schwartz method. Generalized linear mixed-effects models compared the pre-VAD and post-VAD eGFR for the cohort and sub-groups with and without pre-VAD renal dysfunction (pre-VAD eGFR renal dysfunction. AKI affected 60.3% (38 of 63), with similar rates in those with and without pre-existing renal dysfunction. Within the cohort, the nadir eGFR occurred 1 day post-operatively (62.9 ml/min/1.73 m(2); IQR, 51.2-88.9 ml/min/1.73 m(2); p renal dysfunction experienced the greatest improvement in the eGFR (β = 0.0051 vs β = 0.0013, p Renal dysfunction is prevalent in children with heart failure undergoing VAD placement. Although peri-operative AKI is common, renal function improves substantially in the first post-operative week and for months thereafter. This is particularly pronounced in those with pre-VAD renal impairment, suggesting that VADs may facilitate recovery and maintenance of kidney function in children with advanced heart failure. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Novel nonsurgical left ventricular assist device and system.

Science.gov (United States)

Misiri, Juna; DeSimone, Christopher V; Park, Soon J; Kushwaha, Sudhir S; Friedman, Paul A; Bruce, Charles J; Asirvatham, Samuel J

2013-01-01

Treatment options for advanced stages of congestive heart failure remain limited. Left ventricular assist devices (LVADs) have emerged as a means to support failing circulation. However, these devices are not without significant risk such as major open chest surgery. We utilized a novel approach for device placement at the aorto-left atria continuity as a site to create a conduit capable of accommodating a percutaneous LVAD system. We designed and developed an expandable nitinol based device for placement at this site to create a shunt between the LA and aorta. Our experiments support this anatomic location as an accessible and feasible site for accommodation of an entirely percutaneous LVAD. The novelty of this approach would bypass the left ventricle, and thereby minimize complications and morbidities associated with current LVAD placement. Copyright © 2013 Elsevier Inc. All rights reserved.

Cost-effectiveness of left ventricular assist devices for patients with end-stage heart failure: analysis of the French hospital discharge database.

Science.gov (United States)

Tadmouri, Abir; Blomkvist, Josefin; Landais, Cécile; Seymour, Jerome; Azmoun, Alexandre

2018-02-01

Although left ventricular assist devices (LVADs) are currently approved for coverage and reimbursement in France, no French cost-effectiveness (CE) data are available to support this decision. This study aimed at estimating the CE of LVAD compared with medical management in the French health system. Individual patient data from the 'French hospital discharge database' (Medicalization of information systems program) were analysed using Kaplan-Meier method. Outcomes were time to death, time to heart transplantation (HTx), and time to death after HTx. A micro-costing method was used to calculate the monthly costs extracted from the Program for the Medicalization of Information Systems. A multistate Markov monthly cycle model was developed to assess CE. The analysis over a lifetime horizon was performed from the perspective of the French healthcare payer; discount rates were 4%. Probabilistic and deterministic sensitivity analyses were performed. Outcomes were quality-adjusted life years (QALYs) and incremental CE ratio (ICER). Mean QALY for an LVAD patient was 1.5 at a lifetime cost of €190 739, delivering a probabilistic ICER of €125 580/QALY [95% confidence interval: 105 587 to 150 314]. The sensitivity analysis showed that the ICER was mainly sensitive to two factors: (i) the high acquisition cost of the device and (ii) the device performance in terms of patient survival. Our economic evaluation showed that the use of LVAD in patients with end-stage heart failure yields greater benefit in terms of survival than medical management at an extra lifetime cost exceeding the €100 000/QALY. Technological advances and device costs reduction shall hence lead to an improvement in overall CE. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

The successful implantation of continuous-flow left ventricular assist device as a destination therapy in Korea: echocardiographic assessment.

Science.gov (United States)

Lee, Ga Yeon; Park, Sung-Ji; Kim, Sujin; Choi, Namgyung; Jeong, Dong Seop; Jeon, Eun-Seok; Lee, Young Tak

2014-01-01

Left ventricular assist device (LVAD) is a good treatment option for the patients ineligible for cardiac transplantation. Several studies have demonstrated that a ventricular assist device improves the quality of life and prognosis of the patients with end-stage heart failure. A 75-yr-old man debilitated with New York Heart Association (NYHA) functional class III-IV due to severe left ventricular systolic dysfunction received LVAD implantation as a destination therapy. The patient was discharged with improved functional status (NYHA functional class II) after appropriate cardiac rehabilitation and education about how to manage the device and potential emergency situations. This is the first case of successful continuous-flow LVAD implantation as a destination therapy in Korea.

[Mechanical circulatory support saves lives -- three years' experience of the newly established assist device program at Semmelweis University, Budapest, Hungary].

Science.gov (United States)

Fazekas, Levente; Sax, Balázs; Hartyánszky, István; Pólos, Miklós; Horkay, Ferenc; Varga, Tamás; Rácz, Kristóf; Németh, Endre; Székely, Andrea; Paulovich, Erzsébet; Heltai, Krisztina; Zima, Endre; Szabolcs, Zoltán; Merkely, Béla

2015-03-29

Since the celebration of the 20th anniversary of the first heart transplantation in Hungary in 2012 the emerging need for modern heart failure management via mechanical circulatory support has evolved. In May 2012 the opening of a new heart failure and transplant unit with 9 beds together with the procurement of necessary devices at Semmelweis University accomplished this need. The aim of the authors was to report their initial experience obtained in this new cardiac assist device program. Since May, 2012, mechanical circulatory support system was applied in 89 cases in 72 patients. Indication for support were end stage heart failure refractory to medical treatment and acute left or right heart failure. Treatment was initiated for acute graft failure after heart transplantation in 27 cases, for end stage heart failure in 24 cases, for acute myocardial infarction in 21 cases, for acute postcardiotomy heart failure in 14 cases, for severe respiratory insufficiency in 2 cases and for drug intoxication in one case. Among the 30 survivor of the whole program 13 patients were successfully transplanted. The available devices can cover all modalities of current bridge therapy from short term support through medium support to heart transplantation or long term support and destination therapy. These conditions made possible the successful start of a new cardiac assist device program.

Post-transplant outcomes in pediatric ventricular assist device patients: A PediMACS-Pediatric Heart Transplant Study linkage analysis.

Science.gov (United States)

Sutcliffe, David L; Pruitt, Elizabeth; Cantor, Ryan S; Godown, Justin; Lane, John; Turrentine, Mark W; Law, Sabrina P; Lantz, Jodie L; Kirklin, James K; Bernstein, Daniel; Blume, Elizabeth D

2017-12-13

Pediatric ventricular assist device (VAD) support as bridge to transplant has improved waitlist survival, but the effects of pre-implant status and VAD-related events on post-transplant outcomes have not been assessed. This study is a linkage analysis between the PediMACS and Pediatric Heart Transplant Study databases to determine the effects of VAD course on post-transplant outcomes. Database linkage between October 1, 2012 and December 31, 2015 identified 147 transplanted VAD patients, the primary study group. The comparison cohort was composed of 630 PHTS patients without pre-transplant VAD support. The primary outcome was post-transplant survival, with secondary outcomes of post-transplant length of stay, freedom from infection and freedom from rejection. At implant, the VAD cohort was INTERMACS Profile 1 in 33 (23%), Profile 2 in 89 (63%) and Profile 3 in 14 (10%) patients. The VAD cohort was older, larger, and less likely to have congenital heart disease (p < 0.0001). However, they had greater requirements for inotrope and ventilator support and increased liver and renal dysfunction (p < 0.0001), both of which normalized at transplant after device support. Importantly, there were no differences in 1-year post-transplant survival (96% vs 93%, p = 0.3), freedom from infection (81% vs 79%, p = 0.9) or freedom from rejection (71% vs 74%, p = 0.87) between cohorts. Pediatric VAD patients have post-transplant outcomes equal to that of medically supported patients, despite greater pre-implant illness severity. Post-transplant survival, hospital length of stay, infection and rejection were not affected by patient acuity at VAD implantation or VAD-related complications. Therefore, VAD as bridge to transplant mitigates severity of illness in children. Copyright © 2017 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Right ventricular failure after implantation of a continuous-flow left ventricular assist device

DEFF Research Database (Denmark)

Cordtz, Johan Joakim; Nilsson, Jens C; Hansen, Peter B

2014-01-01

Right ventricular failure (RVF) is a significant complication after implantation of a left ventricular assist device. We aimed to identify haemodynamic changes in the early postoperative phase that predicted subsequent development of RVF in a cohort of HeartMate II (HMII) implanted patients....

Developing an Anti-Xa-Based Anticoagulation Protocol for Patients with Percutaneous Ventricular Assist Devices.

Science.gov (United States)

Sieg, Adam; Mardis, B Andrew; Mardis, Caitlin R; Huber, Michelle R; New, James P; Meadows, Holly B; Cook, Jennifer L; Toole, J Matthew; Uber, Walter E

2015-01-01

Because of the complexities associated with anticoagulation in temporary percutaneous ventricular assist device (pVAD) recipients, a lack of standardization exists in their management. This retrospective analysis evaluates current anticoagulation practices at a single center with the aim of identifying an optimal anticoagulation strategy and protocol. Patients were divided into two cohorts based on pVAD implanted (CentriMag (Thoratec; Pleasanton, CA) / TandemHeart (CardiacAssist; Pittsburgh, PA) or Impella (Abiomed, Danvers, MA)), with each group individually analyzed for bleeding and thrombotic complications. Patients in the CentriMag/TandemHeart cohort were subdivided based on the anticoagulation monitoring strategy (activated partial thromboplastin time (aPTT) or antifactor Xa unfractionated heparin (anti-Xa) values). In the CentriMag/TandemHeart cohort, there were five patients with anticoagulation titrated based on anti-Xa values; one patient developed a device thrombosis and a major bleed, whereas another patient experienced major bleeding. Eight patients received an Impella pVAD. Seven total major bleeds in three patients and no thrombotic events were detected. Based on distinct differences between the devices, anti-Xa values, and outcomes, two protocols were created to guide anticoagulation adjustments. However, anticoagulation in patients who require pVAD support is complex with constantly evolving anticoagulation goals. The ideal level of anticoagulation should be individually determined using several coagulation laboratory parameters in concert with hemodynamic changes in the patient's clinical status, the device, and the device cannulation.

Risk stratification in patients with advanced heart failure requiring biventricular assist device support as a bridge to cardiac transplantation.

Science.gov (United States)

Cheng, Richard K; Deng, Mario C; Tseng, Chi-hong; Shemin, Richard J; Kubak, Bernard M; MacLellan, W Robb

2012-08-01

Prior studies have identified risk factors for survival in patients with end-stage heart failure (HF) requiring left ventricular assist device (LVAD) support. However, patients with biventricular HF may represent a unique cohort. We retrospectively evaluated a consecutive cohort of 113 adult, end-stage HF patients at University of California Los Angeles Medical Center who required BIVAD support between 2000 and 2009. Survival to transplant was 66.4%, with 1-year actuarial survival of 62.8%. All patients were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Level 1 or 2 and received Thoratec (Pleasanton, CA) paracorporeal BIVAD as a bridge to transplant. Univariate analyses showed dialysis use, ventilator use, extracorporal membrane oxygenation use, low cardiac output, preserved LV ejection fraction (restrictive physiology), normal-to-high sodium, low platelet count, low total cholesterol, low high-density and high-density lipoprotein, low albumin, and elevated aspartate aminotransferase were associated with increased risk of death. We generated a scoring system for survival to transplant. Our final model, with age, sex, dialysis, cholesterol, ventilator, and albumin, gave a C-statistic of 0.870. A simplified system preserved a C-statistic of 0.844. Patients were divided into high-risk or highest-risk groups (median respective survival, 367 and 17 days), with strong discrimination between groups for death. We have generated a scoring system that offers high prognostic ability for patients requiring BIVAD support and hope that it may assist in clinical decision making. Further studies are needed to prospectively validate our scoring system. Copyright © 2012 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Computational fluid dynamics analysis of a maglev centrifugal left ventricular assist device.

Science.gov (United States)

Burgreen, Greg W; Loree, Howard M; Bourque, Kevin; Dague, Charles; Poirier, Victor L; Farrar, David; Hampton, Edward; Wu, Z Jon; Gempp, Thomas M; Schöb, Reto

2004-10-01

The fluid dynamics of the Thoratec HeartMate III (Thoratec Corp., Pleasanton, CA, U.S.A.) left ventricular assist device are analyzed over a range of physiological operating conditions. The HeartMate III is a centrifugal flow pump with a magnetically suspended rotor. The complete pump was analyzed using computational fluid dynamics (CFD) analysis and experimental particle imaging flow visualization (PIFV). A comparison of CFD predictions to experimental imaging shows good agreement. Both CFD and experimental PIFV confirmed well-behaved flow fields in the main components of the HeartMate III pump: inlet, volute, and outlet. The HeartMate III is shown to exhibit clean flow features and good surface washing across its entire operating range.

Biventricular assist using a portable driver in combination with implanted devices: preliminary experience.

Science.gov (United States)

von Segesser, L K; Tkebuchava, T; Leskosek, B; Marty, B; Pei, Y C; Turina, M

1997-01-01

Left ventricular assist systems with portable drive units are increasingly used in the clinical setting. However, such systems usually are not suitable for right ventricular support, and therefore, in the case of biventricular heart failure, they must be combined with other support devices that require additional drive consoles. As a result, most of the benefits of the wearable drive units (early mobilization and outpatient care) are lost. This present study was performed to evaluate biventricular support with implanted assist devices and a portable DC/battery-powered driver (Thoratec TLC-II). Electronic control by nonvolatile RAM accessible via RS232 interface, internal backup emergency battery, and optional manual activation are additional features of this 6 kg biventricular drive unit. In 3 bovine experiments (body weight 70 +/- 5 kg) partial cardiopulmonary bypass (CPB) was established, and two ventricular assist devices were implanted into a preperitoneal pocket on each side after connection to the right atrium and the pulmonary artery and to the left atrium and aorta, respectively. After weaning the patient from CPB, activated coagulation time (ACT) was kept at greater than 180 s, and biventricular support with the portable driver was activated. After 10 min, mean device flow stabilized at 3.5 +/- 0 L/min and remained at that level throughout the ensuing 6 h (3.5 +/- 0.3 L/min; NS). The heart rate moved from 130 +/- 13 beats per minute (bpm) at the end of CPB to 116 +/- 13 bpm after 10 min of assist (p < 0.05). Right atrial pressure moved from 11 +/- 2 mm Hg at the end of CPB to 13 +/- 3 mm Hg after 10 min of assist (not significant [NS]). Mean pulmonary artery pressure was 18 +/- mm Hg at the end of CPB and 17 +/- 5 mm Hg after 10 min of assist (NS). Left atrial pressure was 10 +/- 1 mm Hg at the end of CPB and 13 +/- 3 mm Hg after 10 min of assist (NS). Mean aortic pressure was 73 +/- 11 mm Hg at the end of CPB and 77 +/- 3 mm Hg after 10 min of assist (NS

Heat Generation in Axial and Centrifugal Flow Left Ventricular Assist Devices.

Science.gov (United States)

Yost, Gardner; Joseph, Christine Rachel; Royston, Thomas; Tatooles, Antone; Bhat, Geetha

Despite increasing use of left ventricular assist devices (LVADs) as a surgical treatment for advanced heart failure in an era of improved outcomes with LVAD support, the mechanical interactions between these pumps and the cardiovascular system are not completely understood. We utilized an in vitro mock circulatory loop to analyze the heat production incurred by operation of an axial flow and centrifugal flow LVAD. A HeartMate II and a HeartWare HVAD were connected to an abbreviated flow loop and were implanted in a viscoelastic gel. Temperature was measured at the surface of each LVAD. Device speed and fluid viscosity were altered and, in the HeartMate II, as artificial thrombi were attached to the inflow stator, impeller, and outflow stator. The surface temperatures of both LVADs increased in all trials and reached a plateau within 80 minutes of flow initiation. Rate of heat generation and maximum system temperature were greater when speed was increased, when viscosity was increased, and when artificial thrombi were attached to the HeartMate II impeller. Normal operation of these two widely utilized LVADs results in appreciable heat generation in vitro. Increased pump loading resulted in more rapid heat generation, which was particularly severe when a large thrombus was attached to the impeller of the HeartMate II. While heat accumulation in vivo is likely minimized by greater dissipation in the blood and soft tissues, focal temperature gains with the pump housing of these two devices during long-term operation may have negative hematological consequences.

Left ventricular assist device implantation via left thoracotomy: alternative to repeat sternotomy.

Science.gov (United States)

Pierson, Richard N; Howser, Renee; Donaldson, Terri; Merrill, Walter H; Dignan, Rebecca J; Drinkwater, Davis C; Christian, Karla G; Butler, Javed; Chomsky, Don; Wilson, John R; Clark, Rick; Davis, Stacy F

2002-03-01

Repeat sternotomy for left ventricular assist device insertion may result in injury to the right heart or patent coronary grafts, complicating intraoperative and postoperative management. In 4 critically ill patients, left thoracotomy was used as an alternative to repeat sternotomy. Anastomosis of the outflow conduit to the descending thoracic aorta provided satisfactory hemodynamic support.

The Ventricular Assist Device in the Life of the Child: A Phenomenological Pediatric Study.

Science.gov (United States)

van Manen, Michael A

2017-05-01

What is it like for a child to live with an artificial heart? The use of some medical therapies in children requires developmental considerations, is associated with psychosocial consequences, and calls for ethical sensitivities. A critical case is the ventricular assist device (VAD), a mechanical pump used to support the functioning of a failing heart. As a pediatric therapy, the device can be used as a temporary solution for poor heart function, a bridge to transplantation or recovery, or as a destination therapy. While the mechanical-technical operation of the VAD is well understood, the clinical-technical aspects of young people living with this device are largely unexplored. Drawing on interviews of school-aged children, the aim of this phenomenological study is to explore how a VAD may structure or condition a child's meaningful experience of their world outside the hospital. The driveline of an implanted VAD is the peripheral attachment, extruding through the skin to connect the controller-power supply. The materiality of the device may be interruptive, restrictive, and disturbing to the psycho-physical being and sense of self-identity of the child as a child. And while a child equipped with a VAD is not necessarily conspicuous among other children, the child may experience the device as an exposing presence, while living with the worry of a caregiver who takes on the role not simply of parent but of watchful health professional. A phenomenological understanding of the VAD should assist parents and caregiving health professionals knowing how to deal with specific issues arising in the life of the VAD child.

De novo development of eosinophilic myocarditis with left ventricular assist device support as bridge to transplant.

Science.gov (United States)

Pereira, Naveen L; Park, Soon J; Daly, Richard C; Kushwaha, Sudhir S; Edwards, William D

2010-10-01

The de novo development of myocarditis during left ventricular assist device support for dilated cardiomyopathy has not been previously described. We report a case of severe eosinophilic myocarditis associated with the use of leukotriene-receptor antagonist montelukast that developed during left ventricular assist device support accompanied by intra-device thrombus formation that was hemodynamically tolerated and subsequently discovered in the explanted heart. There may be no visible change in cardiac function as assessed by echocardiography, but the diagnosis should be entertained with the development of peripheral eosinophilia. Copyright © 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Identification and Management of Pump Thrombus in the HeartWare Left Ventricular Assist Device System: A Novel Approach Using Log File Analysis.

Science.gov (United States)

Jorde, Ulrich P; Aaronson, Keith D; Najjar, Samer S; Pagani, Francis D; Hayward, Christopher; Zimpfer, Daniel; Schlöglhofer, Thomas; Pham, Duc T; Goldstein, Daniel J; Leadley, Katrin; Chow, Ming-Jay; Brown, Michael C; Uriel, Nir

2015-11-01

The study sought to characterize patterns in the HeartWare (HeartWare Inc., Framingham, Massachusetts) ventricular assist device (HVAD) log files associated with successful medical treatment of device thrombosis. Device thrombosis is a serious adverse event for mechanical circulatory support devices and is often preceded by increased power consumption. Log files of the pump power are easily accessible on the bedside monitor of HVAD patients and may allow early diagnosis of device thrombosis. Furthermore, analysis of the log files may be able to predict the success rate of thrombolysis or the need for pump exchange. The log files of 15 ADVANCE trial patients (algorithm derivation cohort) with 16 pump thrombus events treated with tissue plasminogen activator (tPA) were assessed for changes in the absolute and rate of increase in power consumption. Successful thrombolysis was defined as a clinical resolution of pump thrombus including normalization of power consumption and improvement in biochemical markers of hemolysis. Significant differences in log file patterns between successful and unsuccessful thrombolysis treatments were verified in 43 patients with 53 pump thrombus events implanted outside of clinical trials (validation cohort). The overall success rate of tPA therapy was 57%. Successful treatments had significantly lower measures of percent of expected power (130.9% vs. 196.1%, p = 0.016) and rate of increase in power (0.61 vs. 2.87, p file parameters can potentially predict the likelihood of successful tPA treatments and if validated prospectively, could substantially alter the approach to thrombus management. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Bridge to transplantation using paracorporeal biventricular assist devices or the syncardia temporary total artificial heart: is there a difference?

Science.gov (United States)

Nguyen, A; Pozzi, M; Mastroianni, C; Léger, P; Loisance, D; Pavie, A; Leprince, P; Kirsch, M

2015-06-01

Biventricular support can be achieved using paracorporeal ventricular assist devices (p-BiVAD) or the Syncardia temporary total artificial heart (t-TAH). The purpose of the present study was to compare survival and morbidity between these devices. Data from 2 French neighboring hospitals were reviewed. Between 1996 and 2009, 148 patients (67 p-BiVADs and 81 t-TAH) underwent primary, planned biventricular support. There were 128 (86%) males aged 44±13 years. Preoperatively, p-BiVAD recipients had significantly lower systolic and diastolic blood pressures, more severe hepatic cytolysis and higher white blood cell counts than t-TAH recipients. In contrast, t-TAH patients had significantly higher rates of pre-implant ECLS and hemofiltration. Mean support duration was 79±100 days for the p-BiVAD group and 71±92 for t-TAH group (P=0.6). Forty two (63%) p-BiVAD recipients were bridged to transplantation (39, 58%) or recovery (3, 5%), whereas 51 (63%) patients underwent transplantation in the t-TAH group. Death on support was similar between groups (p-BiVAD, 26 (39%); t-TAH, 30 (37%); P=0.87). Survival while on device was not significantly different between patient groups and multivariate analysis showed that only preimplant diastolic blood pressure and alanine amino-transferase levels were significant predictors of death. Post-transplant survival in the p-BiVAD group was 76±7%, 70±8%, and 58±9% at 1, 3, and 5 years after transplantation, respectively, and was similar to that of the t-TAH group (77±6%, 72±6%, and 70±7%, P=0.60). Survival while on support and up to 5 years after heart transplantation was not significantly different in patients supported by p-BiVADs or t-TAH. Multivariate analysis revealed that survival while on transplantation was not affected by the type of device implanted.

Impact of Tricuspid Valve Surgery at the Time of Left Ventricular Assist Device Insertion on Postoperative Outcomes

OpenAIRE

Dunlay, Shannon M.; Deo, Salil V.; Park, Soon J.

2015-01-01

Tricuspid regurgitation (TR) is common in patients with heart failure undergoing left ventricular assist device (LVAD) implantation. Whether the TR should be surgically managed at the time of LVAD surgery is controversial.

The Ventricular Assist Device in the Life of the Child: A Phenomenological Pediatric Study

Science.gov (United States)

van Manen, Michael A.

2017-01-01

What is it like for a child to live with an artificial heart? The use of some medical therapies in children requires developmental considerations, is associated with psychosocial consequences, and calls for ethical sensitivities. A critical case is the ventricular assist device (VAD), a mechanical pump used to support the functioning of a failing heart. As a pediatric therapy, the device can be used as a temporary solution for poor heart function, a bridge to transplantation or recovery, or as a destination therapy. While the mechanical-technical operation of the VAD is well understood, the clinical-technical aspects of young people living with this device are largely unexplored. Drawing on interviews of school-aged children, the aim of this phenomenological study is to explore how a VAD may structure or condition a child’s meaningful experience of their world outside the hospital. The driveline of an implanted VAD is the peripheral attachment, extruding through the skin to connect the controller-power supply. The materiality of the device may be interruptive, restrictive, and disturbing to the psycho-physical being and sense of self-identity of the child as a child. And while a child equipped with a VAD is not necessarily conspicuous among other children, the child may experience the device as an exposing presence, while living with the worry of a caregiver who takes on the role not simply of parent but of watchful health professional. A phenomenological understanding of the VAD should assist parents and caregiving health professionals knowing how to deal with specific issues arising in the life of the VAD child. PMID:28682718

Perioperative management of calves undergoing implantation of a left ventricular assist device.

Science.gov (United States)

Wilson, D V; Kantrowitz, A; Pacholewicz, J; Salat, O; Paules, B R; Zhou, Y; Dawe, E J

2000-01-01

To describe perioperative management of calves that underwent left lateral thoracotomy, aortic cross-clamping, partial left heart bypass and implantation of a left ventricular assist device. A total of 43 healthy castrated male calves, weighing 121 +/- 24 kg. Diazepam (mean +/- SD, 0.26 +/- 0.07 mg/kg), ketamine (5.9 +/- 2.17 mg/kg) and isoflurane were used in the anesthetic management of calves undergoing implantation of a left ventricular assist device in the descending thoracic aorta. Other adjunctive agents administered were fentanyl (11 +/- 5.4 microg/kg), lidocaine (4.9 +/- 3.19 mg/kg), bupivacaine (0.75%) and butorphanol (0.49 +/- 0.13 mg/kg). None of the calves regurgitated at induction or during intubation. A tube was used to drain the rumen and prevent bloat during the procedure. Partial left heart bypass was used to perfuse the caudal half of the body during the period of aortic cross clamp and device implantation. Initial mean systemic blood pressure was 96 +/- 25 mm Hg, and pressures measured in the auricular artery increased during aortic cross-clamping and bypass. Vasoconstrictor therapy was required to treat caudal arterial hypotension during the procedure in 9 calves. Mean systemic arterial pressures returned to baseline values by the end of the anesthetic period. Initial mean pulmonary arterial pressures (PAP) were 22 +/- 3 mm Hg. A significant but transient increase in pulmonary arterial pressure occurred after both heparin and protamine administration. The described anesthetic protocol was effective for thoracotomy and implantation of an intra-aortic left ventricular assist device in normal calves. Partial left ventricular bypass was a useful adjunct during the period of aortic cross clamp. The doses of heparin and protamine administered were effective. Responsibility to monitor oxygenation of the cranial half of the animal continues during the bypass period as hypoxemia due to pulmonary dysfunction will not be detected by the perfusionist.

Assistive Devices

Science.gov (United States)

If you have a disability or injury, you may use a number of assistive devices. These are tools, products or types of equipment that help you perform tasks and activities. They may help you move around, see, communicate, eat, or get ...

Machines versus medication for biventricular heart failure: focus on the total artificial heart.

Science.gov (United States)

Arabia, Francisco A; Moriguchi, Jaime D

2014-09-01

The medical/surgical management of advanced heart failure has evolved rapidly over the last few decades. With better understanding of heart failure pathophysiology, new pharmacological agents have been introduced that have resulted in improvements in survival. For those patients that fail to improve, mechanical circulatory support with left ventricular assist devices and total artificial hearts (TAHs) have served as a beneficial bridge to transplantation. The TAH has continued to play a significant role as a bridge to transplantation in patients with biventricular failure and more selected indications that could not be completely helped with left ventricular assist devices. Improved survival with the TAH has resulted in more patients benefiting from this technology. Improvements will eventually lead to a totally implantable device that will permanently replace the failing human heart.

Right ventricular functional analysis utilizing first pass radionuclide angiography for pre-operative ventricular assist device planning: a multi-modality comparison.

Science.gov (United States)

Avery, Ryan; Day, Kevin; Jokerst, Clinton; Kazui, Toshinobu; Krupinski, Elizabeth; Khalpey, Zain

2017-10-10

Advanced heart failure treated with a left ventricular assist device is associated with a higher risk of right heart failure. Many advanced heart failures patients are treated with an ICD, a relative contraindication to MRI, prior to assist device placement. Given this limitation, left and right ventricular function for patients with an ICD is calculated using radionuclide angiography utilizing planar multigated acquisition (MUGA) and first pass radionuclide angiography (FPRNA), respectively. Given the availability of MRI protocols that can accommodate patients with ICDs, we have correlated the findings of ventricular functional analysis using radionuclide angiography to cardiac MRI, the reference standard for ventricle function calculation, to directly correlate calculated ejection fractions between these modalities, and to also assess agreement between available echocardiographic and hemodynamic parameters of right ventricular function. A retrospective review from January 2012 through May 2014 was performed to identify advanced heart failure patients who underwent both cardiac MRI and radionuclide angiography for ventricular functional analysis. Nine heart failure patients (8 men, 1 woman; mean age of 57.0 years) were identified. The average time between the cardiac MRI and radionuclide angiography exams was 38.9 days (range: 1 - 119 days). All patients undergoing cardiac MRI were scanned using an institutionally approved protocol for ICD with no device-related complications identified. A retrospective chart review of each patient for cardiomyopathy diagnosis, clinical follow-up, and echocardiogram and right heart catheterization performed during evaluation was also performed. The 9 patients demonstrated a mean left ventricular ejection fraction (LVEF) using cardiac MRI of 20.7% (12 - 40%). Mean LVEF using MUGA was 22.6% (12 - 49%). The mean right ventricular ejection fraction (RVEF) utilizing cardiac MRI was 28.3% (16 - 43%), and the mean RVEF calculated by

76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-06-22

... information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a..., please contact AnnMarie Williams, Conference Management Staff, at 301-796-5966, at least 7 days in...

Psychological distress in patients with a left ventricular assist device and their partners : An exploratory study

NARCIS (Netherlands)

Brouwers, C.J.; Denollet, J.; Caliskan, K.; de Jonge, N.; Constantinescu, A.; Young, Q.; Kaan, A.; Pedersen, S.S.

2015-01-01

Background: Left ventricular assist device (LVAD) therapy is increasingly used in patients with advanced heart failure,and may have a significant psychological impact on both patients and their partners. Hence, we examined the distress levels of LVAD patients and their partners. Methods: Anxiety,

Psychological distress in patients with a left ventricular assist device and their partners : an exploratory study

NARCIS (Netherlands)

Brouwers, Corline; Denollet, Johan; Caliskan, Kadir; de Jonge, N; Constantinescu, Alina; Young, Quincy; Kaan, Annemarie; Pedersen, Susanne S

BACKGROUND: Left ventricular assist device (LVAD) therapy is increasingly used in patients with advanced heart failure, and may have a significant psychological impact on both patients and their partners. Hence, we examined the distress levels of LVAD patients and their partners. METHODS: Anxiety,

Bridge to transplantation with a left ventricular assist device.

Science.gov (United States)

Jung, Jae Jun; Sung, Kiick; Jeong, Dong Seop; Kim, Wook Sung; Lee, Young Tak; Park, Pyo Won

2012-04-01

A 61-year-old female patient was diagnosed with dilated cardiomyopathy with severe left ventricle dysfunction. Two days after admission, continuous renal replacement therapy was performed due to oliguria and lactic acidosis. On the fifth day, an intra-aortic balloon pump was inserted due to low cardiac output syndrome. Beginning 4 days after admission, she was supported for 15 days thereafter with an extracorporeal left ventricular assist device (LVAD) because of heart failure with multi-organ failure. A heart transplant was performed while the patient was stabilized with the LVAD. She developed several complications after the surgery, such as cytomegalovirus pneumonia, pulmonary tuberculosis, wound dehiscence, and H1N1 infection. On postoperative day 19, she was discharged from the hospital with close follow-up and treatment for infection. She received follow-up care for 10 months without any immune rejection reaction.

Exercise therapy for an older patient with left ventricular assist device.

Science.gov (United States)

Park, Won Hah; Seo, Yong Gon; Sung, Ji Dong

2014-06-01

A left ventricular assist device (LVAD) is a mechanical circulation support implanted for patients with end-stage heart failure. It may be used either as a bridge to cardiac transplantation or as a destination therapy. The health of a 75-year-old man with a medical history of systolic heart failure worsened. Therefore, he was recommended to have implanted a LVAD (Thoratec Corp.) as a destination therapy. After the surgery, he was enrolled in patient cardiac rehabilitation for the improvement of dyspnea and exercise capacity. In results, there is an improvement on his exercise capacity and quality of life. For the first time in Korea, we reported a benefit of exercise therapy after being implanted with a LVAD.

Comparison of total artificial heart and biventricular assist device support as bridge-to-transplantation.

Science.gov (United States)

Cheng, Allen; Trivedi, Jaimin R; Van Berkel, Victor H; Massey, H Todd; Slaughter, Mark S

2016-10-01

The use of left ventricular assist devices (LVAD) has increased significantly in the last decade. However, right heart dysfunction remains a problem despite the improved outcomes with continuous-flow LVADs. Surgical options for bridge to transplantation (BTT) in patients with biventricular failure are total artificial heart (TAH) or biventricular support (BiVAD). This study examines the differences in pre- and post-transplantation outcomes and survival in patients with TAH or BiVAD support as BTT. The United Network of Organ Sharing database was retrospectively queried from January 2005 to December 2014 to identify adult patients undergoing heart transplantation (n = 17,022). Patients supported with either TAH (n = 212) or BiVAD (n = 366) at the time of transplantation were evaluated. Pre- and post-transplantation Kaplan-Meier survival curves were examined. Cox regression model was used to study the hazard ratios of the association between TAH versus BiVAD support and post-transplant survival. The median age of the study groups was 49.8 ± 12.9 (TAH) and 47.2 ± 13.9 (BiVAD) years (range 18-74 years). There were more men, 87% versus 74%, in the TAH group (p < 0.0001) with greater body mass index, 27.3 ± 5.2 versus 25.6 ± 4.7 (p < 0.0001), compared to those with BiVADs. Creatinine was higher, 1.7 + 1.2 versus 1.3 + 0.8 mg/dL (p < 0.0001), in the TAH group before transplant. The 30-day, one-, and three-year post-transplantation survival was 88%, 78%, and 67%, respectively, for patients with TAH support versus 93%, 83%, and 73% (p = 0.06) for patients with BiVAD support. Cox regression model shows pre-transplant creatinine (HR = 1.21, p = 0.008) is associated with a lower post-transplant survival. TAH is not associated with a worse post-transplant survival (p = 0.1). There was no difference in wait-list survival in patients supported with TAH or BiVAD (p = 0.8). Although there has been a recent

Design of wheel-type walking-assist device

International Nuclear Information System (INIS)

Jung, Seung Ho; Kim, Seung Ho; Kim, Chang Hoi; Seo, Yong Chil; Jung, Kyung Min; Lee, Sung Uk

2006-03-01

In this research, a outdoor wheel-type walking-assist device is developed to help an elder having a poor muscular strength at legs for walking, sitting and standing up easily at outdoors, and also for going and downing stairs. In conceptually designing, the environments of an elder's activity, the size of an elder's body and a necessary function of helping an elder are considered. This device has 4 wheels for stability. When an elder walks in incline plane with the proposed device, a rear-wing is rotated to keep the supporting device horizontal, regardless of an angle of inclination. A height-controlling device, which can control the height of the supporting device for adjusting an elder's height, is varied vertically to help an elder to sit and stand-up easily. Moreover, a outdoor wheel-type walking-assist device is conceptually designed and is made. In order to design it, the preview research is investigated firstly. On the basis of the proposed walking-assist device, the outdoor walking-assist device is designed and made. The outdoor wheel-type walking-assist device can go and down stairs automatically. This device go up and down the stair of having maximum 20cm height and an angle of 25 degrees with maximum 4 sec/stairs speed, and move at flatland with 60cm/sec speed

Improved Approach With Subcostal Exchange of the HeartMate II Left Ventricular Assist Device: Difference in On and Off Pump?

Science.gov (United States)

Gaffey, Ann C; Chen, Carol W; Chung, Jennifer J; Phillips, Emily; Wald, Joyce; Williams, Matthew L; Low, David W; Acker, Michael A; Atluri, Pavan

2017-11-01

The HeartMate II (St. Jude Medical, Inc, St. Paul, MN [previously Thoratec]) left ventricular assist device (LVAD) exchange has traditionally involved a redo sternotomy. Alternate minimally invasive subcostal approaches have the advantage of avoiding sternal reentry, excessive bleeding, and prolonged recovery. This retrospective review included patients who underwent an exchange from May 2009 to March 2016. The patients were divided into three cohorts: (1) redo sternotomy, (2) subcostal approach involving cardiopulmonary bypass (CPB) (ON-CPB SC), and (3) subcostal approach off the CPB pump (OFF-CPB SC). Data pertaining to patients' baseline characteristics and outcomes were collected and analyzed. From May 1, 2009 to July 31, 2016, 33 HeartMate II LVAD exchanges were performed. There were 11 redo sternotomies and 22 subcostal exchanges, 12 of which were in the OFF-CPB SC group. There was no significant difference among the groups in terms of age (p = 0.75), sex (p = 0.95), and indication for exchange (p = 0.94). There was a higher red blood cell transfusion requirement within the sternotomy cohort (p rates were equivalent among the cohorts. Exchange of the HeartMate II LVAD can be accomplished with significantly improved recovery time and transfusion requirement through a less invasive subcostal approach when compared with sternotomy. The subcostal approach can be performed safely both on and off cardiopulmonary bypass. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Brain-controlled body movement assistance devices and methods

Energy Technology Data Exchange (ETDEWEB)

Leuthardt, Eric C.; Love, Lonnie J.; Coker, Rob; Moran, Daniel W.

2017-01-10

Methods, devices, systems, and apparatus, including computer programs encoded on a computer storage medium, for brain-controlled body movement assistance devices. In one aspect, a device includes a brain-controlled body movement assistance device with a brain-computer interface (BCI) component adapted to be mounted to a user, a body movement assistance component operably connected to the BCI component and adapted to be worn by the user, and a feedback mechanism provided in connection with at least one of the BCI component and the body movement assistance component, the feedback mechanism being configured to output information relating to a usage session of the brain-controlled body movement assistance device.

Fluoroscopy-Guided Resolution of Ingested Thrombus Leading to Functional Disturbance of a Continuous-Flow Left Ventricular Assist Device

Directory of Open Access Journals (Sweden)

Jens Garbade

2012-01-01

Full Text Available The third generation of left ventricular assist devices (LVADs has been shown to improve outcome and quality of life in patients suffering from acute and chronic heart failure. However, VAD-associated complications are still a challenge in the clinical practice. Here we report the resolution of a mobile thrombus formation in the proximity of the inflow cannula of a third generation of LVADs (HVAD Pump, HeartWare, Inc. in a patient with chronic heart failure 4 months after implantation.

Left ventricular assist device therapy in advanced heart failure

DEFF Research Database (Denmark)

Gustafsson, Finn; Rogers, Joseph G

2017-01-01

Despite improvements in pharmacological therapy and pacing, prognosis in advanced heart failure (HF) remains poor, with a 1-year mortality of 25-50%. While heart transplantation provides excellent survival and quality of life for eligible patients, only a few can be offered this treatment due...

Right ventricular longitudinal strain and right ventricular stroke work index in patients with severe heart failure: left ventricular assist device suitability for transplant candidates.

Science.gov (United States)

Cameli, M; Bernazzali, S; Lisi, M; Tsioulpas, C; Croccia, M G; Lisi, G; Maccherini, M; Mondillo, S

2012-09-01

Right ventricular (RV) systolic function has a critical role in determining the clinical outcome and the success of using left ventricular assist devices in patients with refractory heart failure. RV deformation analysis by speckle tracking echocardiography (STE) has recently allowed the analysis of RV longitudinal function. Using cardiac catheterization as the reference standard, this study aimed to explore the correlation between RV longitudinal function by STE and RV stroke work index (RVSWI) among patients referred for cardiac transplantation. Right heart catheterization and transthoracic echo-Doppler were simultaneously performed in 47 patients referred for cardiac transplant assessment due to refractory heart failure (ejection fraction 25.1 ± 4.5%). Thermodilution RV stroke volume and invasive pulmonary pressures were used to obtain RVSWI. RV longitudinal strain (RVLS) by STE was assessed averaging RV free-wall segments (free-wall RVLS). We also calculated. Tricuspid S' and tricuspid annular plane systolic excursion (TAPSE). No significant correlation was observed for TAPSE on tricuspid S' with RV stroke volume (r = 0.14 and r = 0.06, respectively). A close negative correlation between free-wall RVLS and RVSWI was found (r = -0.82; P rights reserved.

Right heart failure and "failure to thrive" after left ventricular assist device: clinical predictors and outcomes.

Science.gov (United States)

Baumwol, Jay; Macdonald, Peter S; Keogh, Anne M; Kotlyar, Eugene; Spratt, Phillip; Jansz, Paul; Hayward, Christopher S

2011-08-01

This study determined predictors of early post-operative right heart failure (RHF) and its consequences, as well as predictors of those who clinically thrive longer term after insertion of a continuous-flow left ventricular assist device (LVAD). Pre-operative and latest follow-up data were analyzed for 40 consecutive patients who received third-generation centrifugal-flow LVADs. RHF was defined using previously described criteria, including post-operative inotropes, pulmonary vasodilator use, or right-sided mechanical support. Patients were also categorized according to clinical outcomes after LVAD insertion. LVADs were implanted as a bridge to transplantation (BTT) in 33 patients and as destination therapy in 7. Before LVAD implant, 22 patients were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 1, and 17 were at level 2. Temporary mechanical assistance was present in 50% of the cohort at LVAD implantation. The 6-month survival/progression to transplant was 92.5%. Average LVAD support time was 385 days (range, 21-1,011 days). RHF developed postoperatively in 13 of 40 patients (32.5%). RHF patients had more severe pre-operative tricuspid incompetence than non-RHF patients. The BTT patients with evidence of RHF had poorer survival to transplant (6 of 11 [54.5%]) than those without RHF (20 of 22 [90.9%]), p = 0.027). There were no other hemodynamic or echocardiographic predictors of short-term RHF. After LVAD, 22 of the 40 patients (55%) thrived clinically. For BTT patients, 20 of 21 (95%) of those who thrived progressed to transplant or were alive at latest follow-up vs 6 of 12 (50%) of those who failed to thrive (FTT; p thrived. Early post-operative RHF results in poorer survival/progression to transplantation for BTT patients and is predicted by greater pre-operative tricuspid incompetence. The most important predictor for those who will clinically thrive longer-term after LVAD insertion is younger age. Crown Copyright © 2011

A new "twist" on right heart failure with left ventricular assist systems.

Science.gov (United States)

Houston, Brian A; Shah, Keyur B; Mehra, Mandeep R; Tedford, Ryan J

2017-07-01

Despite significant efforts to predict and prevent right heart failure, it remains a leading cause of morbidity and mortality after implantation of left ventricular assist systems (LVAS). In this Perspective, we review the underappreciated anatomic and physiologic principles that govern the relationship between left and right heart function and contribute to this phenomenon. This includes the importance of considering the right ventricle (RV) and pulmonary arterial circuit as a coupled system; the contribution of the left ventricle (LV) to RV contractile function and the potential negative impact of acutely unloading the LV; the influence of the pericardium and ventricular twist on septal function; the role of RV deformation in reduced mechanical efficiency after device placement; and the potential of ongoing stressors of an elevated right-sided preload. We believe an appreciation of these complex issues is required to fully understand the expression of the unique phenotypes of right heart failure after LVAS implantation and for developing better prognostic and therapeutic strategies. Copyright © 2017 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Wearable Assistive Devices for the Blind

OpenAIRE

Velazquez, Ramiro

2016-01-01

Assistive devices are a key aspect in wearable systems for biomedical applications, as they represent potential aids for people with physical and sensory disabilities that might lead to improvements in the quality of life. This chapter focuses on wearable assistive devices for the blind. It intends to review the most significant work done in this area, to present the latest approaches for assisting this population and to understand universal design concepts for the development of wearable ass...

Multicenter Evaluation of Octreotide as Secondary Prophylaxis in Patients With Left Ventricular Assist Devices and Gastrointestinal Bleeding.

Science.gov (United States)

Shah, Keyur B; Gunda, Sampath; Emani, Sitaramesh; Kanwar, Manreet K; Uriel, Nir; Colombo, Paolo C; Uber, Patricia A; Sears, Melissa L; Chuang, Joyce; Farrar, David J; Brophy, Donald F; Smallfield, George B

2017-11-01

Gastrointestinal (GI) bleeding is one of the most common complications after continuous-flow left ventricular assist device implantation. More than one third of patients with incident bleed go on to develop recurrent GI bleeding. Octreotide, a somatostatin analog, is proposed to reduce the risk of recurrent GI bleeding in this population. This multicenter, retrospective analysis evaluated 51 continuous-flow left ventricular assist device patients who received secondary prophylaxis with octreotide after their index GI bleed from 2009 to 2015. All patients had a hospitalization for GI bleed and received octreotide after discharge. Patient demographics, medical and medication history, and clinical characteristics of patients who rebled after receiving octreotide were compared with non-rebleeders. These data were also compared with matched historical control patients previously enrolled in the HMII (HeartMate II) clinical trials, none of whom received octreotide, to provide a context for the bleeding rates. Twelve patients (24%) who received secondary octreotide prophylaxis developed another GI bleed, whereas 39 (76%) did not. There were similar intergroup demographics; however, significantly more bleeders had a previous GI bleeding history before left ventricular assist device placement (33% versus 5%; P =0.02) and greater frequency of angiodysplasia confirmed during endoscopy (58% versus 23%; P =0.03). Fewer patients in this study experienced a recurrent GI bleed compared with a matched historical control group that did not receive octreotide (24% versus 43%; P =0.04). Patients with continuous-flow left ventricular assist device receiving secondary prophylaxis with octreotide had a significantly lower GI bleed recurrence compared with historical controls not treated with octreotide. Additional prospective studies are needed to confirm these data. © 2017 American Heart Association, Inc.

Flow Visualization of Three-Dimensionality Inside the 12 cc Penn State Pulsatile Pediatric Ventricular Assist Device

OpenAIRE

Roszelle, Breigh N.; Deutsch, Steven; Manning, Keefe B.

2010-01-01

In order to aid the ongoing concern of limited organ availability for pediatric heart transplants, Penn State has continued development of a pulsatile Pediatric Ventricular Assist Device (PVAD). Initial studies of the PVAD observed an increase in thrombus formation due to differences in flow field physics when compared to adult sized devices, which included a higher degree of three-dimensionality. This unique flow field brings into question the use of 2D planar particle image velocimetry (PIV...

Comparative analysis of von Willebrand factor profiles after implantation of left ventricular assist device and total artificial heart.

Science.gov (United States)

Reich, H J; Morgan, J; Arabia, F; Czer, L; Moriguchi, J; Ramzy, D; Esmailian, F; Lam, L; Dunhill, J; Volod, O

2017-08-01

Essentials Bleeding is a major source of morbidity during mechanical circulatory support. von Willebrand factor (VWF) multimer loss may contribute to bleeding. Different patterns of VWF multimer loss were seen with the two device types. This is the first report of total artificial heart associated VWF multimer loss. Background Bleeding remains a challenge during mechanical circulatory support and underlying mechanisms are incompletely understood. Functional von Willebrand factor (VWF) impairment because of loss of high-molecular-weight multimers (MWMs) produces acquired von Willebrand disease (VWD) after left ventricular assist device (LVAD). Little is known about VWF multimers with total artificial hearts (TAHs). Here, VWF profiles with LVADs and TAHs are compared using a VWD panel. Methods VWD evaluations for patients with LVAD or TAH (2013-14) were retrospectively analyzed and included: VWF activity (ristocetin cofactor, VWF:RCo), VWF antigen (VWF:Ag), ratio of VWF:RCo to VWF:Ag, and quantitative VWF multimeric analysis. Results Twelve patients with LVADs and 12 with TAHs underwent VWD evaluation. All had either normal (47.8%) or elevated (52.2%) VWF:RCo, normal (26.1%) or elevated (73.9%) VWF:Ag and 50.0% were disproportional (ratio ≤ 0.7). Multimeric analysis showed abnormal patterns in all patients with LVADs: seven with high MWM loss; five with highest MWM loss. With TAH, 10/12 patients had abnormal patterns: all with highest MWM loss. High MWM loss correlated with presence of LVAD and highest MWM loss with TAH. Increased low MWMs were detected in 22/24. Conclusion Using VWF multimeric analysis, abnormalities after LVAD or TAH were detected that would be missed with measurements of VWF level alone: loss of high MWM predominantly in LVAD, loss of highest MWM in TAH, and elevated levels of low MWM in both. This is the first study to describe TAH-associated highest MWM loss, which may contribute to bleeding. © 2017 International Society on Thrombosis and

Conventional radiography and computed tomography of cardiac assist devices

Energy Technology Data Exchange (ETDEWEB)

Scheffel, Hans; Stolzmann, Paul; Desbiolles, Lotus; Leschka, Sebastian; Frauenfelder, Thomas; Schertler, Thomas; Marincek, Borut; Alkadhi, Hatem [University Hospital Zurich, Institute of Diagnostic Radiology, Zurich (Switzerland); Wilhelm, Markus J.; Lachat, Mario [University Hospital Zurich, Clinic for Cardiovascular Surgery, Zurich (Switzerland)

2009-09-15

Patients intended for circulatory support by cardiac assist devices (CAD) usually suffer from end-stage acute or chronic heart failure. Since the introduction of CAD in 1963 by DeBakey and coworkers, the systems have gone through a substantial evolution and have been increasingly used in the intervening decades. The spectrum of CAD includes a variety of systems serving to assist the systolic function of the left ventricle, the right ventricle, or both. Conventional radiography and multislice spiral computed tomography (CT) are the most commonly used radiological techniques for imaging patients with a CAD. CT is very useful for evaluating CAD systems by using both two- and three-dimensional reconstructions of the volumetric data sets. The two techniques together allow for the comprehensive assessment of patients with devices by imaging the in- and outflow cannulae, the anastomoses, the position of the pump, as well as associated complications. A close collaboration with cardiac surgeons with expertise in the field of circulatory support is deemed necessary for adequate image interpretation. This article describes the technical diversity of the currently available CAD systems. The imaging characteristics on conventional radiography and multislice spiral CT as well as the typical complications of their use are demonstrated. (orig.)

Assessment of Safety and Effectiveness of the Extracorporeal Continuous-Flow Ventricular Assist Device (BR16010) Use as a Bridge-to-Decision Therapy for Severe Heart Failure or Refractory Cardiogenic Shock: Study Protocol for Single-Arm Non-randomized, Uncontrolled, and Investigator-Initiated Clinical Trial.

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Fukushima, Norihide; Tatsumi, Eisuke; Seguchi, Osamu; Takewa, Yoshiaki; Hamasaki, Toshimitsu; Onda, Kaori; Yamamoto, Haruko; Hayashi, Teruyuki; Fujita, Tomoyuki; Kobayashi, Junjiro

2018-06-08

The management of heart failure patients presenting in a moribund state remains challenging, despite significant advances in the field of ventricular assist systems. Bridge to decision involves using temporary devices to stabilize the hemodynamic state of such patients while further assessment is performed and a decision can be made regarding patient management. The purpose of this study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Dicision_01) is to assess the safety and effectiveness of the newly developed extracorporeal continuous-flow ventricular assist system employing a disposable centrifugal pump with a hydrodynamically levitated bearing (BR16010) use as a bridge-to-decision therapy for patients with severe heart failure or refractory cardiogenic shock. NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. It is conducted at the National Cerebral and Cardiovascular Center in Japan. A total of nine patients will be enrolled in the study. The study was planned using Simon's minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other ventricular assist devices (VADs) for the purpose of bridge to transplantation (BTT) during 30 days after implantation will be considered study successes. For right ventricular assistance, withdrawal of tal device due to right ventricular function recovery within 30 days after implantation will be considered a study success. Secondary objectives include changes in brain natriuretic peptide levels (7 days after implantation of a trial device and the day of withdrawal of a trial device), period of mechanical ventricular support, changes in left ventricular ejection fraction (7 days after implantation of a trial device

Myocardial changes in patients with end-stage heart failure during continuous flow left ventricular assist device support

NARCIS (Netherlands)

Lok, S.I.

2013-01-01

With respect to the clinical outcome, cf-LVADs provide sufficient ventricular unloading and circulatory support. The post-operative mortality and morbidity in our centre are comparable with other recent experiences with this device. Based on these data, Heart Mate II (HM II) LVAD therapy can be

Left ventricular assist device implantation in a patient who had previously undergone apical myectomy for hypertrophic cardiomyopathy.

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Cho, Yang Hyun; Deo, Salil V; Topilsky, Yan; Grogan, Martha A; Park, Soon J

2012-03-01

Apical hypertrophy is a rare variant of hypertropic cardiomyopathy. These patients may present with end-stage congestive heart failure subsequent to long standing diastolic dysfunction. We report the technique for left ventricular assist device insertion in a patient with previous apical myectomy for hypertrophic cardiomyopathy. © 2012 Wiley Periodicals, Inc.

Artificial muscle for end-stage heart failure.

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Tozzi, Piergiorgio; Michalis, Alexandre; Hayoz, Daniel; Locca, Didier; von Segesser, Ludwig K

2012-01-01

We describe a device made of artificial muscle for the treatment of end-stage heart failure as an alternative to current heart assist devices. The key component is a matrix of nitinol wires and aramidic fibers called Biometal muscle (BM). When heated electrically, it produces a motorless, smooth, and lifelike motion. The BM is connected to a carbon fiber scaffold, tightening the heart and providing simultaneous assistance to the left and right ventricles. A pacemaker-like microprocessor drives the contraction of the BM. We tested the device in a dedicated bench model of diseased heart. It generated a systolic pressure of 75 mm Hg and ejected a maximum of 330 ml/min, with an ejection fraction of 12%. The device required a power supply of 6 V, 250 mA. This could be the beginning of an era in which BMs integrate or replace the mechanical function of natural muscles.

Left ventricular assist device: exercise capacity evolution and rehabilitation added value.

Science.gov (United States)

Lamotte, Michel X; Chimenti, Sara; Deboeck, Gael; Gillet, Alexis; Kacelenenbogen, Raymond; Strapart, Jonathan; Vandeneynde, Frédéric; Van Nooten, Guido; Antoine, Martine

2018-06-01

With more than 15,000 implanted patients worldwide and a survival rate of 80% at 1-year and 59% at 5-years, left ventricular assist device (LVAD) implantation has become an interesting strategy in the management of heart failure patients who are resistant to other kinds of treatment. There are limited data in the literature on the change over time of exercise capacity in LVAD patients, as well as limited knowledge about the beneficial effects that rehabilitation might have on these patients. Therefore, the aim of our study was to evaluate the evolution of exercise capacity on a cohort of patients implanted with the same device (HeartWare © ) and to analyse the potential impact of rehabilitation. Sixty-two patients implanted with a LVAD between June 2011 and June 2015 were screened. Exercise capacity was evaluated by cardiopulmonary exercise testing at 6 weeks, 6 and 12 months after implantation. We have observed significant differences in the exercise capacity and evolution between the trained and non-trained patients. Some of the trained patients nearly normalised their exercise capacity at the end of the rehabilitation programme. Exercise capacity of patient implanted with a HeartWare © LVAD increased in the early period after implantation. Rehabilitation allowed implanted patients to have a significantly better evolution compared to non-rehabilitated patients.

Anchoring in Destination-Therapy Left Ventricular Assist Device Decision Making: A Mechanical Turk Survey.

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Paine, Arcadia M; Allen, Larry A; Thompson, Jocelyn S; McIlvennan, Colleen K; Jenkins, Amy; Hammes, Andrew; Kroehl, Miranda; Matlock, Daniel D

2016-11-01

People with end-stage heart failure may have to decide about destination-therapy left ventricular assist device (DT-LVAD). Individuals facing difficult decisions often rely on heuristics, such as anchoring, which predictably bias decision outcomes. We aimed to investigate whether showing a larger historical Heartmate XVE creates an anchoring effect, making the smaller Heartmate II (HMII) appear more favorable. With the use of Amazon Mechanical Turk, participants watched videos asking them to imagine themselves dying of end-stage heart failure, then were presented the option of LVAD as potentially life-prolonging therapy. Participants were randomized to a control group who were only shown the HMII device, and the intervention group who saw the XVE device before the HMII. Participants then completed surveys. A total of 487 participants completed the survey (control = 252; intervention = 235); 79% were affect likelihood of accepting the LVAD, it did affect device perception. This article highlights an important point with clinical implications: factors such as anchoring have the potential to inappropriately influence perceptions and decisions and should be carefully considered in research and practice. Copyright © 2016 Elsevier Inc. All rights reserved.

Left Ventricular Assist Devices

Directory of Open Access Journals (Sweden)

Khuansiri Narajeenron

2017-04-01

Full Text Available Audience: The audience for this classic team-based learning (cTBL session is emergency medicine residents, faculty, and students; although this topic is applicable to internal medicine and family medicine residents. Introduction: A left ventricular assist device (LVAD is a mechanical circulatory support device that can be placed in critically-ill patients who have poor left ventricular function. After LVAD implantation, patients have improved quality of life.1 The number of LVAD patients worldwide continues to rise. Left-ventricular assist device patients may present to the emergency department (ED with severe, life-threatening conditions. It is essential that emergency physicians have a good understanding of LVADs and their complications. Objectives: Upon completion of this cTBL module, the learner will be able to: 1 Properly assess LVAD patients’ circulatory status; 2 appropriately resuscitate LVAD patients; 3 identify common LVAD complications; 4 evaluate and appropriately manage patients with LVAD malfunctions. Method: The method for this didactic session is cTBL.

Exercise physiology, testing, and training in patients supported by a left ventricular assist device.

Science.gov (United States)

Loyaga-Rendon, Renzo Y; Plaisance, Eric P; Arena, Ross; Shah, Keyur

2015-08-01

The left ventricular assist device (LVAD) is an accepted treatment alternative for the management of end-stage heart failure. As we move toward implantation of LVADs in less severe cases of HF, scrutiny of functional capacity and quality of life becomes more important. Patients demonstrate improvements in exercise capacity after LVAD implantation, but the effect is less than predicted. Exercise training produces multiple beneficial effects in heart failure patients, which would be expected to improve quality of life. In this review, we describe factors that are thought to participate in the persistent exercise impairment in LVAD-supported patients, summarize current knowledge about the effect of exercise training in LVAD-supported patients, and suggest areas for future research. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Left ventricular assist device (lvad design features: literature review

Directory of Open Access Journals (Sweden)

Yu. V. Bogdanova

2014-01-01

Full Text Available More than 8 million people in our country suffer from heart failure. About one million of these people die each year [1]. The problem of ventricular assist device creating - a mechanical device used for partial or complete replacement of heart function - is investigated for a long time (according to [2] just in our country since the 1970s. Today plenty of encouraging results are received. There is a number of VAD models which are successfully applied to patients with heart failure. After implantation, patients conduct a way of life that is normal in many respects: they are in the family, often they have an opportunity to work in their former specialty. Some of them live with the device about 8 years [3].According to [4] for 2010 the estimated total number of long-term devices implanted in the United States per year is over 1,700 (the population of the U.S. is 305 million, compared with over 430 per year in Europe (the population of Europe is 731 million. Unfortunately, people who need a heart transplant are much more.The principle of VAD is that being connected to the left ventricle with one cannula and to the ascending aorta with the other cannula the pump fully or partially replaces the function of the natural heart. This scheme allows the use of VAD in two ways: as a "bridge to transplantation" when the device is used temporarily until the donor heart is found, and a "bridge to recovery", when through the use of VAD the function of the heart muscle is recovered.VAD system can be divided into three subsystems: blood pump, power supply system and control system (Fig. 1.Each subsystem can be the subject of separate study. Special role in the development of VAD plays medical side of the issue. Successful research and development require interaction with qualified professionals in this field. The development of VAD is a multidisciplinary problem which demands fulfilment of a number of requirements.One of the most active programs in implantation of

Ventricular assist device use in single ventricle congenital heart disease.

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Carlo, Waldemar F; Villa, Chet R; Lal, Ashwin K; Morales, David L

2017-11-01

As VAD have become an effective therapy for end-stage heart failure, their application in congenital heart disease has increased. Single ventricle congenital heart disease introduces unique physiologic challenges for VAD use. However, with regard to the mixed clinical results presented within this review, we suggest that patient selection, timing of implant, and center experience are all important contributors to outcome. This review focuses on the published experience of VAD use in single ventricle patients and details physiologic challenges and novel approaches in this growing pediatric and adult population. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The Use of Pediatric Ventricular Assist Devices in Children's Hospitals From 2000 to 2010: Morbidity, Mortality, and Hospital Charges.

Science.gov (United States)

Mansfield, Robert T; Lin, Kimberly Y; Zaoutis, Theoklis; Mott, Antonio R; Mohamad, Zeinab; Luan, Xianqun; Kaufman, Beth D; Ravishankar, Chitra; Gaynor, J William; Shaddy, Robert E; Rossano, Joseph W

2015-07-01

The use of ventricular assist devices has increased dramatically in adult heart failure patients. However, the overall use, outcome, comorbidities, and resource utilization of ventricular assist devices in pediatric patients have not been well described. We sought to demonstrate that the use of ventricular assist devices in pediatric patients has increased over time and that mortality has decreased. A retrospective study of the Pediatric Health Information System database was performed for patients 20 years old or younger undergoing ventricular assist device placement from 2000 to 2010. None. Four hundred seventy-five pediatric patients were implanted with ventricular assist devices during the study period: 69 in 2000-2003 (era 1), 135 in 2004-2006 (era 2), and 271 in 2007-2010 (era 3). Median age at ventricular assist device implantation was 6.0 years (interquartile range, 0.5-13.8), and the proportion of children who were 1-12 years old increased from 29% in era 1 to 47% in era 3 (p = 0.002). The majority of patients had a diagnosis of cardiomyopathy; this increased from 52% in era 1 to 72% in era 3 (p = 0.003). Comorbidities included arrhythmias (48%), pulmonary hypertension (16%), acute renal failure (34%), cerebrovascular disease (28%), and sepsis/systemic inflammatory response syndrome (34%). Two hundred forty-seven patients (52%) underwent heart transplantation and 327 (69%) survived to hospital discharge. Hospital mortality decreased from 42% in era 1 to 25% in era 3 (p = 0.004). Median hospital length of stay increased (37 d [interquartile range, 12-64 d] in era 1 vs 69 d [interquartile range, 35-130] in era 3; p interquartile range, $227,052-$853,318] in era 1 vs $1,577,983 [interquartile range, $874,463-$2,280,435] in era 3; p < 0.001). Factors associated with increased mortality include age less than 1 year (odds ratio, 2.04; 95% CI, 1.01-3.83), acute renal failure (odds ratio, 2.1; 95% CI, 1.26-3.65), cerebrovascular disease (odds ratio, 2.1; 95% CI, 1

Assistive Devices for Students with Disabilities.

Science.gov (United States)

Wisniewski, Lech; Sedlak, Robert

1992-01-01

Describes a variety of devices that can assist students with disabilities. Highlights recently developed devices for students with specific learning disabilities, and with vision, hearing, health, physical, and speech and language impairments. The devices can help rehabilitate, reeducate, facilitate normalcy, or augment current functioning. (GLR)

Early Right Ventricular Assist Device Use in Patients Undergoing Continuous-Flow Left Ventricular Assist Device Implantation: Incidence and Risk Factors From the Interagency Registry for Mechanically Assisted Circulatory Support.

Science.gov (United States)

Kiernan, Michael S; Grandin, E Wilson; Brinkley, Marshall; Kapur, Navin K; Pham, Duc Thinh; Ruthazer, Robin; Rame, J Eduardo; Atluri, Pavan; Birati, Edo Y; Oliveira, Guilherme H; Pagani, Francis D; Kirklin, James K; Naftel, David; Kormos, Robert L; Teuteberg, Jeffrey J; DeNofrio, David

2017-10-01

To investigate preimplant risk factors associated with early right ventricular assist device (RVAD) use in patients undergoing continuous-flow left ventricular assist device (LVAD) surgery. Patients in the Interagency Registry for Mechanically Assisted Circulatory Support who underwent primary continuous-flow-LVAD surgery were examined for concurrent or subsequent RVAD implantation within 14 days of LVAD. Risk factors for RVAD implantation and the combined end point of RVAD or death within 14 days of LVAD were assessed with stepwise logistic regression. We compared survival between patients with and without RVAD using Kaplan-Meier method and Cox proportional hazards modeling. Of 9976 patients undergoing continuous-flow-LVAD implantation, 386 patients (3.9%) required an RVAD within 14 days of LVAD surgery. Preimplant characteristics associated with RVAD use included interagency registry for mechanically assisted circulatory support patient profiles 1 and 2, the need for preoperative extracorporeal membrane oxygenation or renal replacement therapy, severe preimplant tricuspid regurgitation, history of cardiac surgery, and concomitant procedures other than tricuspid valve repair at the time of LVAD. Hemodynamic determinants included elevated right atrial pressure, reduced pulmonary artery pulse pressure, and reduced stroke volume. The final model demonstrated good performance for both RVAD implant (area under the curve, 0.78) and the combined end point of RVAD or death within 14 days (area under the curve, 0.73). Compared with patients receiving an isolated LVAD, patients requiring RVAD had decreased 1- and 6-month survival: 78.1% versus 95.8% and 63.6% versus 87.9%, respectively ( P The need for RVAD implantation after LVAD is associated with indices of global illness severity, markers of end-organ dysfunction, and profiles of hemodynamic instability. © 2017 American Heart Association, Inc.

Introduction of assistive devices: home nurses' practices and beliefs.

Science.gov (United States)

Roelands, Marc; Van Oost, Paulette; Depoorter, Anne Marie; Buysse, Ann; Stevens, Veerle

2006-04-01

This paper reports a study describing home nurses' intention and current practices regarding introducing assistive devices, and investigating whether their practice is related to social cognitive factors (attitudes, subjective norms and self-efficacy). Home nurses not only care for patients in particular medical domains, but also educate and guide them towards more independence. Patients with age-related disabilities in mobility and self-care might benefit from the use of assistive devices. A home nurse might be the first and only person to discuss the disability and use of an assistive device. Therefore, home nurses' beliefs about the introduction of assistive devices could affect their daily practices. A cross-sectional study was conducted with a convenience sample of 64 home nurses chosen from a random sample of home nursing departments. The home nurses completed a self-administered questionnaire. The Theory of Planned Behaviour framework was used to develop the social cognitive measures regarding each of the six steps distinguished in the introduction of assistive devices. Home nurses had positive attitudes and high levels of intention, subjective norm and self-efficacy towards most steps of the decision process to introduce assistive devices. In a multiple linear regression analysis, attitude and self-efficacy predicted intention to introduce assistive devices to older clients with disabilities. Intention was correlated to home nurses' current practices. The findings suggest that conditions are present to involve home nurses more explicitly in the introduction of assistive devices to their patients. Social cognitive factors should be taken into account when developing interventions that aim to support home nurses to do this.

Is exercise training safe and beneficial in patients receiving left ventricular assist device therapy?

Science.gov (United States)

Alsara, Osama; Perez-Terzic, Carmen; Squires, Ray W; Dandamudi, Sanjay; Miranda, William R; Park, Soon J; Thomas, Randal J

2014-01-01

Because a limited number of patients receive heart transplantation, alternative therapies, such as left ventricular assist device (LVAD) therapy, have emerged. Published studies have shown that LVAD implantation, by itself, improves exercise tolerance to the point where it is comparable to those with mild heart failure. The improvement in exercise capacity is maximally achieved 12 weeks after LVAD therapy and can continue even after explantation of the device. This effect varies, depending on the type of LVAD and exercise training. The available data in the literature on safety and benefits of exercise training in patients after LVAD implantation are limited, but the data that are available suggest that training trends to be safe and have an impact on exercise capacity in LVAD patients. Although no studies were identified on the role of cardiac rehabilitation programs in the management of LVAD patients, it appears that cardiac rehabilitation programs offer an ideal setting for the provision of supervised exercise training in this patient group.

Focused review on transthoracic echocardiographic assessment of patients with continuous axial left ventricular assist devices.

Science.gov (United States)

Topilsky, Yan; Maltais, Simon; Oh, Jae K; Atchison, Fawn W; Perrault, Louis P; Carrier, Michel; Park, Soon J

2011-02-08

Left ventricular assist devices (LVADs) are systems for mechanical support for patients with end-stage heart failure. Preoperative, postoperative and comprehensive followup with transthoracic echocardiography has a major role in LVAD patient management. In this paper, we will present briefly the hemodynamics of axial-flow LVAD, the rationale, and available data for a complete and organized echocardiographic assessment in these patients including preoperative assessment, postoperative and long-term evaluation.

General and acute care surgical procedures in patients with left ventricular assist devices.

Science.gov (United States)

Arnaoutakis, George J; Bittle, Gregory J; Allen, Jeremiah G; Weiss, Eric S; Alejo, Jennifer; Baumgartner, William A; Shah, Ashish S; Wolfgang, Christopher L; Efron, David T; Conte, John V

2014-04-01

Left ventricular assist devices (LVADs) have become common as a bridge to heart transplant as well as destination therapy. Acute care surgical (ACS) problems in this population are prevalent but remain ill-defined. Therefore, we reviewed our experience with ACS interventions in LVAD patients. A total of 173 patients who received HeartMate(®) XVE or HeartMate(®) II (HMII) LVADs between December 2001 and March 2010 were studied. Patient demographics, presentation of ACS problem, operative intervention, co-morbidities, transplantation, complications, and survival were analyzed. A total of 47 (27 %) patients underwent 67 ACS procedures at a median of 38 days after device implant (interquartile range 15-110), with a peri-operative mortality rate of 5 % (N = 3). Demographics, device type, and acuity were comparable between the ACS and non-ACS groups. A total of 21 ACS procedures were performed emergently, eight were urgent, and 38 were elective. Of 29 urgent and emergent procedures, 28 were for abdominal pathology. In eight patients, the cause of the ACS problem was related to LVADs or anticoagulation. Cumulative survival estimates revealed no survival differences if patients underwent ACS procedures (p = 0.17). Among HMII patients, transplantation rates were unaffected by an ACS intervention (p = 0.2). ACS problems occur frequently in LVAD patients and are not associated with adverse outcomes in HMII patients. The acute care surgeon is an integral member of a comprehensive approach to effective LVAD management.

Heart Failure

Science.gov (United States)

... Other diseases. Chronic diseases — such as diabetes, HIV, hyperthyroidism, hypothyroidism, or a buildup of iron (hemochromatosis) or ... transplantation or support with a ventricular assist device. Prevention The key to preventing heart failure is to ...

Efficient adders for assistive devices

Directory of Open Access Journals (Sweden)

Mansi Jhamb

2017-02-01

Full Text Available The Body sensor network [IEEE 802.15] is a wireless communication network consisting of assistive devices which are of prime importance in medical applications. The delay critical and power hungry blocks in these assistive devices are designed so that they consume less power, have low latency and require a lesser area on chip. In this paper, we present a qualitative as well as a quantitative analysis of an asynchronous pipelined adder design with two latest computation completion sensing approaches based on Pseudo NMOS logic and other based on C-element. The Pseudo NMOS based completion sensing approach provides a maximum improvement of 76.92% in critical path delay at supply voltage of 1.2 V and the maximum drop in power dissipation has been observed at a supply voltage of 1.1 V which is 85.60% as compared to C-element based completion sensing approach. Even at low voltages such as 0.8 V, there is a significant improvement in speed and power which is 75.64% and 74.79% respectively. Since the adder is the most widely used component in all present day assistive devices, this analysis acts as a pointer for the application of asynchronous pipelined circuits with efficient Pseudo NMOS based completion sensing approach in low voltage/low power rehabilitative devices.

Ventricular assist device elicits serum natural IgG that correlates with the development of primary graft dysfunction following heart transplantation.

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See, Sarah B; Clerkin, Kevin J; Kennel, Peter J; Zhang, Feifan; Weber, Matthew P; Rogers, Kortney J; Chatterjee, Debanjana; Vasilescu, Elena R; Vlad, George; Naka, Yoshifumi; Restaino, Susan W; Farr, Maryjane A; Topkara, Veli K; Colombo, Paolo C; Mancini, Donna M; Schulze, P Christian; Levin, Bruce; Zorn, Emmanuel

2017-08-01

Pre-transplant sensitization is a limiting factor in solid-organ transplantation. In heart transplants, ventricular assist device (VAD) implantation has been associated with sensitization to human leukocyte antigens (HLA). The effect of VAD on non-HLA antibodies is unclear. We have previously shown that polyreactive natural antibodies (Nabs) contribute to pre-sensitization in kidney allograft recipients. Here we assessed generation of Nabs after VAD implantation in pre-transplant sera and examined their contribution to cardiac allograft outcome. IgM and IgG Nabs were tested in pre-transplant serum samples collected from 206 orthotopic heart transplant recipients, including 128 patients with VAD (VAD patients) and 78 patients without VAD (no-VAD patients). Nabs were assessed by testing serum reactivity to apoptotic cells by flow cytometry and to the generic oxidized epitope, malondialdehyde, by enzyme-linked immunosorbent assay. No difference was observed in serum levels of IgM Nabs between VAD and no-VAD patients. However, serum IgG Nabs levels were significantly increased in VAD compared with no-VAD patients. This increase was likely due to the presence of the VAD, as revealed by lower serum IgG Nabs levels before implantation. Elevated pre-transplant IgG Nabs level was associated with development of primary graft dysfunction (PGD). Our study demonstrates that VAD support elicits IgG Nabs reactive to apoptotic cells and oxidized epitopes. These findings further support broad and non-specific B-cell activation by VAD, resulting in IgG sensitization. Moreover, the association of serum IgG Nabs levels with development of PGD suggests a possible role for these antibodies in the inflammatory reaction accompanying this complication. Copyright © 2017 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Screening for heart transplantation and left ventricular assist system

DEFF Research Database (Denmark)

Lund, Lars H; Trochu, Jean-Noel; Meyns, Bart

2018-01-01

BACKGROUND: Heart transplantation (HTx) and implantable left ventricular assist systems (LVAS) improve outcomes in advanced heart failure but may be underutilized. We hypothesized that screening can identify appropriate candidates. METHODS AND RESULTS: The ScrEEning for advanced Heart Failure...... treatment (SEE-HF) study was a multicentre prospective study screening patients with existing cardiac resynchronization therapy (CRT) and/or implantable cardioverter-defibrillator (ICD) for ejection fraction ≤40% and New York Heart Association (NYHA) class III-IV, and subsequently for guideline-based HTx...

Verification of a computational cardiovascular system model comparing the hemodynamics of a continuous flow to a synchronous valveless pulsatile flow left ventricular assist device.

Science.gov (United States)

Gohean, Jeffrey R; George, Mitchell J; Pate, Thomas D; Kurusz, Mark; Longoria, Raul G; Smalling, Richard W

2013-01-01

The purpose of this investigation is to use a computational model to compare a synchronized valveless pulsatile left ventricular assist device with continuous flow left ventricular assist devices at the same level of device flow, and to verify the model with in vivo porcine data. A dynamic system model of the human cardiovascular system was developed to simulate the support of a healthy or failing native heart from a continuous flow left ventricular assist device or a synchronous pulsatile valveless dual-piston positive displacement pump. These results were compared with measurements made during in vivo porcine experiments. Results from the simulation model and from the in vivo counterpart show that the pulsatile pump provides higher cardiac output, left ventricular unloading, cardiac pulsatility, and aortic valve flow as compared with the continuous flow model at the same level of support. The dynamic system model developed for this investigation can effectively simulate human cardiovascular support by a synchronous pulsatile or continuous flow ventricular assist device.

Development of ventricular assist devices in China: present status, opportunities and challenges.

Science.gov (United States)

Gu, Kaiyun; Chang, Yu; Gao, Bin; Wan, Feng; Loisance, Daniel; Zeng, Yi

2014-08-01

The growing number of heart failure patients and the scarcity of organ donors account for the huge need for the development of mechanical circulatory systems, including ventricular assist devices (VADs) and artificial hearts, in China. Several research programmes on blood pumps have been under way for the last three decades. However, unlike in other countries, the development of VADs has been extremely slow, and no system is currently approved and available for clinical application. There are many reasons for this situation. This article provides an overview of the present development of experimental and clinical research on VADs in China. In addition, the challenges for the clinical development of mechanical circulatory support in China are discussed. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Anesthesia for gastrointestinal endoscopy in patients with left ventricular assist devices: Initial experience with 68 procedures

Directory of Open Access Journals (Sweden)

Basavana G Goudra

2013-01-01

Full Text Available Aims and Objectives: Continuous flow left ventricular assist devices (LVAD have emerged as a reliable treatment option for heart failure. Because of bleeding secondary to anticoagulation, these patients present frequently for gastrointestinal (GI endoscopy. The presently available literature on perioperative management of these patients is extremely limited and is primarily based upon theoretical principles. Materials and Methods: Perioperative records of patients with LVAD undergoing (GI endoscopy between 2008 and 2012 were reviewed. Patient, device and procedure specific information was analyzed. Results: A total of 105 LVADs were implanted, and 68 procedures were performed in 39 patients. The most common indication was GI bleed (48/68, with yearly risk of 8.57% per patient. A total of 63 procedures were performed under deep sedation, with five procedures requiring general anesthesia. Intra-procedure hypotension was managed by fluids and (or vasopressors/inotropes (phenylephrine, ephedrine or milrinone guided by plethysmographic waveform, non-invasive blood pressure (NIBP and LVADs pulsatility index (for HeartMate II/flow pulsatility (for HeartWare. No patient required invasive monitoring and both NIBP and pulse oximeter could be reliably used for monitoring (and guided management in all patients due to the presence of native heart′s pulsatile output. Conclusion: In the presence of residual heart function, with optimal device settings, non-invasive hemodynamic monitoring can be reliably used in these patients while undergoing GI endoscopy under general anesthesia or monitored anesthesia care. Transient hypotensive episodes respond well to fluids/vasopressors without the need of increasing device speed that can be detrimental.

Outcomes of ventricular assist device implantation in children and young adults: the Melbourne experience.

Science.gov (United States)

Shi, William Y; Marasco, Silvana F; Saxena, Pankaj; d'Udekem, Yves; Yong, Matthew S; Mitnovetski, Sergei; Brizard, Christian P; McGiffin, David C; Weintraub, Robert G; Konstantinov, Igor E

2016-12-01

We evaluated our experience with ventricular assist device (VAD) implantation in children and young adults. A total of 64 patients underwent VAD implantation in two centres. The mean age was 15 ± 7.2 years. Thirty-five (55%) patients were under 18 years of age. Devices implanted included the Thoratec Paracorporeal in 30 (47%) patients, Berlin Heart EXCOR in 11 (17%) and VentrAssist in 14 (22%). The diagnosis was cardiomyopathy in 53, congenital heart disease in 11, and graft failure in four patients. There were 10 (16%) in-hospital deaths. Mortality was higher in patients <18 years of age (26% compared with 3.4% for those ≥18 years, P = 0.02). The use of extracorporeal membrane oxygenation prior to VAD implantation was associated with higher mortality (P = 0.006). Seventeen (27%) patients experienced stroke. Nine patients (14%) required change of VAD because of thrombosis. Transplantation was performed in 44 patients after a mean of 131 ± 141 days on VAD, 11 patients died without transplantation and three patients currently await transplantation. The VAD was explanted in six patients because of recovery. Overall survival from VAD implantation was 69% and 61% at 5 and 10 years, respectively. The 5-year post-transplant survival for those bridged with VAD support was 91% and was comparable with a cohort of patients who did not receive a pre-transplant VAD. Children requiring pre-transplant VAD support have a higher mortality and morbidity compared with young adults. Survival after heart transplantation those supported with VADs was similar to patients of similar age who did not require pre-transplant support. © 2015 Royal Australasian College of Surgeons.

Left ventricular assist device exchange: the Toronto General Hospital experience.

Science.gov (United States)

Tsubota, Hideki; Ribeiro, Roberto V P; Billia, Filio; Cusimano, Robert J; Yau, Terrence M; Badiwala, Mitesh V; Stansfield, William E; Rao, Vivek

2017-08-01

As support times for left ventricular assist devices (LVADs) become longer, several complications requiring device exchange may occur. To our knowledge, this is the first Canadian report regarding implantable LVAD exchange. We retrospectively reviewed the cases of consecutive, unique patients implanted with an LVAD between June 2006 and October 2015 at Toronto General Hospital. In total, 122 patients were impanted with an LVAD during the study period. Eight patients required LVAD exchange, and 1 patient had 2 replacements (9 of 122, 7.3%). There were 7 HeartMate II (HMII), 1 HVAD and 1 DuraHeart pumps exchanged. Two of these exchanges occurred early at the time of initial implant, whereas 7 occurred late (range 8-623 d). Six exchanges were made owing to pump thrombosis. Of the 3 exchanges made for other causes, 1 HMII exchange was owing to a driveline fracture, 1 DuraHeart patient had early inflow obstruction requiring exchange to HMII at the initial implant, and the third had a suspected inflow obstruction with no evidence of thrombosis at the time of the procedure. The mean support time before exchange was 225 days, and time from exchange to transplant, death or ongoing support was 245 days. Three patients were successfully bridged to transplant, and at the time of data collection 2 were supported awaiting transplant. Three patients died after a mean duration of 394.3 days (range 78-673 d) of support postreplacement. Four cases were successfully performed using a subcostal approach. Pump thrombosis is the most common cause for LVAD exchange, which can be performed with acceptable morbidity and mortality. The subcostal approach may be the preferred procedure for an HMII exchange when indicated.

Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices

Science.gov (United States)

Pron, G; Ieraci, L; Kaulback, K

2012-01-01

Executive Summary Objective The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions. Clinical Need: Condition and Target Population Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD. Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities. Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs. Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however

Using medical imaging for the detection of adverse events ("incidents") during the utilization of left ventricular assist devices in adult patients with advanced heart failure.

Science.gov (United States)

Kaufmann, Friedrich; Krabatsch, Thomas

2016-05-01

Ventricular assist devices (VAD) are used for mechanical support of the terminally failing heart. Failure of these life supporting systems can be fatal. Early and reliable detection of any upcoming problems is mandatory and is crucial for the outcome. Medical imaging methods are described within this review, which are not only essential for diagnosis of typically VAD-related complications but also for the detection or verification of technical issues. Within this review the utilization of medical imaging equipment for the diagnosis of technical malfunctions or damages of implanted system components is discussed. A newly developed specialized acoustic imaging method for pump thrombosis detection will also be described along with the most common VAD-related medical complications and their respective imaging methods and the limitations induced by the use of the VAD-system.

Totally implantable total artificial heart and ventricular assist device with multipurpose miniature electromechanical energy system.

Science.gov (United States)

Takatani, S; Orime, Y; Tasai, K; Ohara, Y; Naito, K; Mizuguchi, K; Makinouchi, K; Damm, G; Glueck, J; Ling, J

1994-01-01

A multipurpose miniature electromechanical energy system has been developed to yield a compact, efficient, durable, and biocompatible total artificial heart (TAH) and ventricular assist device (VAD). Associated controller-driver electronics were recently miniaturized and converted into hybrid circuits. The hybrid controller consists of a microprocessor and controller, motor driver, Hall sensor, and commutation circuit hybrids. The sizing study demonstrated that all these components can be incorporated in the pumping unit of the TAH and VAD, particularly in the centerpiece of the TAH and the motor housing of the VAD. Both TAH and VAD pumping units will start when their power line is connected to either the internal power pack or the external battery unit. As a redundant driving and diagnostic port, an emergency port was newly added and will be placed in subcutaneous location. In case of system failure, the skin will be cut down, and an external motor drive or a pneumatic driver will be connected to this port to run the TAH. This will minimize the circulatory arrest time. Overall efficiency of the TAH without the transcutaneous energy transmission system was 14-18% to deliver pump outputs of 4-9 L/min against the right and left afterload pressures of 25 and 100 mm Hg. The internal power requirement ranged from 6 to 13 W. The rechargeable batteries such as NiCd or NiMH with 1 AH capacity can run the TAH for 30-45 min. The external power requirement, when TETS efficiency of 75% was assumed, ranged from 8 to 18 W. The accelerated endurance test in the 42 degrees C saline bath demonstrated stable performance over 4 months. Long-term endurance and chronic animal studies will continue toward a system with 5 years durability by the year 2000.

Advances in bioartificial liver assist devices.

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Patzer, J F

2001-11-01

Rapid advances in development of bioartificial liver assist devices (BLADs) are exciting clinical interest in the application of BLAD technology for support of patients with acute liver failure. Four devices (Circe Biomedical HepatAssist, Vitagen ELAD, Gerlach BELS, and Excorp Medical BLSS) that rely on hepatocytes cultured in hollow-fiber membrane technology are currently in various stages of clinical evaluation. Several alternative approaches for culture and perfusion of hepatocytes have been evaluated in preclinical, large animal models of liver failure, or at a laboratory scale. Engineering design issues with respect to xenotransplantation, BLAD perfusion, hepatocyte functionality and culture maintenance, and ultimate distribution of a BLAD to a clinical site are delineated.

Advantages and disadvantages of using intravenous tissue Plasminogen activator as salvage therapy for inoperable HeartWare thrombosis.

Science.gov (United States)

Basken, Robyn; Bazzell, Charles M; Smith, Richard; Janardhanan, Rajesh; Khalpey, Zain

2017-07-01

Device thrombosis is a devastating complication of left ventricular assist devices. The definitive treatment has been device exchange or explant. Evidence of increasing morbidity and mortality with device exchange has shifted strategies toward conservative management. In this report, we detail the use of thrombolytics as salvage therapy in a patient with an occlusive HeartWare ventricular assist device (HeartWare Inc., Framingham, MA) thrombus, resulting in long-term survival without further intervention. © 2017 Wiley Periodicals, Inc.

Renal Function and Outcomes With Use of Left Ventricular Assist Device Implantation and Inotropes in End-Stage Heart Failure: A Retrospective Single Center Study.

Science.gov (United States)

Verma, Sean; Bassily, Emmanuel; Leighton, Shane; Mhaskar, Rahul; Sunjic, Igor; Martin, Angel; Rihana, Nancy; Jarmi, Tambi; Bassil, Claude

2017-07-01

Left ventricular assist device (LVAD) and inotrope therapy serve as a bridge to transplant (BTT) or as destination therapy in patients who are not heart transplant candidates. End-stage heart failure patients often have impaired renal function, and renal outcomes after LVAD therapy versus inotrope therapy have not been evaluated. In this study, 169 patients with continuous flow LVAD therapy and 20 patients with continuous intravenous inotrope therapy were analyzed. The two groups were evaluated at baseline and at 3 and 6 months after LVAD or inotrope therapy was started. The incidence of acute kidney injury (AKI), need for renal replacement therapy (RRT), BTT rate, and mortality for 6 months following LVAD or inotrope therapy were studied. Results between the groups were compared using Mann-Whitney U test and Chi-square with continuity correction or Fischer's exact at the significance level of 0.05. Mean glomerular filtration rate (GFR) was not statistically different between the two groups, with P = 0.471, 0.429, and 0.847 at baseline, 3 and 6 months, respectively. The incidence of AKI, RRT, and BTT was not statistically different. Mortality was less in the inotrope group (P < 0.001). Intravenous inotrope therapy in end-stage heart failure patients is non-inferior for mortality, incidence of AKI, need for RRT, and renal function for 6-month follow-up when compared to LVAD therapy. Further studies are needed to compare the effectiveness of inotropes versus LVAD implantation on renal function and outcomes over a longer time period.

Translation and validation of the assistive technology device predisposition assessment in Greek in order to assess satisfaction with use of the selected assistive device.

Science.gov (United States)

Koumpouros, Yiannis; Papageorgiou, Effie; Karavasili, Alexandra; Alexopoulou, Despoina

2017-07-01

To examine the Assistive Technology Device Predisposition Assessment scale and provide evidence of validity and reliability of the Greek version. We translated and adapted the original instrument in Greek according to the most well-known guidelines recommendations. Field test studies were conducted in a rehabilitation hospital to validate the appropriateness of the final results. Ratings of the different items were statistically analyzed. We recruited 115 subjects who were administered the Form E of the original questionnaire. The experimental analysis conducted revealed a three subscales structure: (i) Adaptability, (ii) Fit to Use, and (iii) Socializing. According to the results of our study the three subscales measure different constructs. Reliability measures (ICC = 0.981, Pearson's correlation = 0.963, Cronbach's α = 0.701) yielded high values. Test-retest outcome showed great stability. This is the first study, at least to the knowledge of the authors, which focuses merely on measuring the satisfaction of the users from the used assistive device, while exploring the Assistive Technology Device Predisposition Assessment - Device Form in such depth. According to the results, it is a stable, valid and reliable instrument and applicable to the Greek population. Thus, it can be used to measure the satisfaction of patients with assistive devices. Implications for Rehabilitation The paper explores the cultural adaptability and applicability of ATD PA - Device Form. ATD PA - Device Form can be used to assess user satisfaction by the selected assistive device. ATD PA - Device Form is a valid and reliable instrument in measuring users' satisfaction in Greekreality.

The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy.

Science.gov (United States)

Pagani, Francis D; Aaronson, Keith D; Kormos, Robert; Mann, Douglas L; Spino, Cathie; Jeffries, Neal; Taddei-Peters, Wendy C; Mancini, Donna M; McNamara, Dennis M; Grady, Kathleen L; Gorcsan, John; Petrucci, Ralph; Anderson, Allen S; Glick, Henry A; Acker, Michael A; Eduardo Rame, J; Goldstein, Daniel J; Pamboukian, Salpy V; Miller, Marissa A; Timothy Baldwin, J

2016-11-01

The National Institutes of Health National Heart, Lung, and Blood Institute convened a working group in March 2008 to discuss how therapies for heart failure (HF) might be best advanced using clinical trials involving left ventricular assist devices (LVAD). This group opined that the field was ready for a trial to assess the use of long-term ventricular assist device therapy in patients who are less ill than patients currently eligible for destination therapy, which resulted in the Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) pilot study. The specific objective of REVIVE-IT was to compare LVAD therapy with optimal medical management in patients with less advanced HF than current LVAD indications to determine if wider application of permanent LVAD use to less ill patients would be associated with improved survival, quality of life, or functional capacity. REVIVE-IT represented an extraordinary effort to provide data from a randomized clinical trial to inform clinicians, scientists, industry, and regulatory agencies about the efficacy and safety of LVAD therapy in a population with less advanced HF. Despite significant support from the medical community, industry, and governmental agencies, REVIVE-IT failed to accomplish its goal. The reasons for its failure are instructive, and the lessons learned from the REVIVE-IT experience are likely to be relevant to any future study of LVAD therapy in a population with less advanced HF. Copyright © 2016 International Society for Heart and Lung Transplantation. All rights reserved.

Design and Evolution of the Asporto Heart Preservation Device.

Science.gov (United States)

Rivard, Andrew L

2015-06-01

The Asporto Heart Preservation Device is a system providing perfusion of cardioplegia to the donor heart using a computer-controlled peristaltic pump in a thermoelectrically cooled and insulated container. In 1998, a user interface was developed at the University of Minnesota consisting of a touch screen and battery-backed microcontroller. Power was supplied by a 120 VAC to 12 VDC converter. An upgrade to the insulated cooler and microcontroller occurred in 2002, which was followed by proof of concept experimental pre-clinical transplants and tests demonstrating the efficacy of the device with isolated donor hearts. During the period between 2002 and 2006, a variety of donor organ containers were developed, modified, and tested to provide an optimal sterile environment and fluid path. Parallel development paths encompass formalized design specifications for final prototypes of the touch screen/microcontroller, organ container, and thermoelectric cooler.

Cost-Effectiveness of Ventricular Assist Device Destination Therapy for Advanced Heart Failure in Duchenne Muscular Dystrophy.

Science.gov (United States)

Magnetta, Defne A; Kang, JaHyun; Wearden, Peter D; Smith, Kenneth J; Feingold, Brian

2018-05-17

Destination ventricular assist device therapy (DT-VAD) is well accepted in select adults with medically refractory heart failure (HF) who are not transplant candidates; however, its use in younger patients with progressive diseases is unclear. We sought to evaluate the cost-effectiveness of DT-VAD in Duchenne muscular dystrophy (DMD) patients with advanced HF. We created a Markov-state transition model (5-year horizon) to compare survival, costs, and quality of life (QOL) between medical management and DT-VAD in DMD with advanced HF. Model input parameters were derived from the literature. We used sensitivity analyses to explore uncertainty around model assumptions. DT-VAD had higher costs ($435,602 vs. $125,696), survival (3.13 vs. 0.60 years), and quality-adjusted survival (1.99 vs. 0.26 years) than medical management. The incremental cost-effectiveness ratio (ICER) for DT-VAD was $179,086 per quality-adjusted life year (QALY). In sensitivity analyses that were widely varied to account for uncertainty in model assumptions, the DT-VAD strategy generally remained more costly and effective than medical management. Only when VAD implantation costs were <$113,142 did the DT-VAD strategy fall below the $100,000/QALY willingness-to-pay threshold commonly considered to be "cost-effective." In this exploratory analysis, DT-VAD for patients with DMD and advanced HF exceeded societal expectations for cost-effectiveness but had an ICER similar to the accepted practice of DT-VAD in adult HF patients. While more experience and research in this population is needed, our analysis suggests that DT-VAD for advanced HF in DMD should not be dismissed solely based on cost.

Pathology in patients with ventricular assist devices: a study of 21 autopsies, 24 ventricular apical core biopsies and 24 explanted hearts.

Science.gov (United States)

Rose, Alan G; Park, Soon J

2005-01-01

Ventricular assist devices (VADs) are used as a bridge to cardiac transplantation or as a permanent or sometimes temporary treatment for end stage heart failure. Our autopsy and surgical pathology experience with VADs prior to August 2002 was reviewed. Noted were patient's age, sex, underlying (UCOD) and proximate causes of death (PCOD), duration of VAD implantation, presence of native or prosthetic valvar disease and organ complications. Myocardium from biopsies and explanted hearts were blindly assessed for coagulative necrosis (CN), contraction bands (CB), myocytolysis (MC), increased eosinophilia (IE), myocyte waviness (MW) and fibrosis (F). Each was graded as either mild (score 1), moderate (score 2) or severe (score 3). Autopsy patients: Twenty-one patients, with mean age 55 years (range 10-73), comprised 10 women and 11 men. UCOD was ischemic disease in 16 patients, dilated cardiomyopathy in 4 and aortic valve disease in 1. The mean duration of VAD implantation was 125.7 days (range 1-1095 days, S.D.=253.6). Five patients had biventricular VADs, and 16 had LVAD only. Acquired aortic valve fusion was noted in three patients. PCOD was VAD related in six, donor heart problem in four, cerebrovascular accident in four, miscellaneous in three, pulmonary hypertension in two and aortic disease in two patients. Morbidity: local liver necrosis in seven, acquired aortic valve disease in four, gut infarction in three, abdominal aortic aneurysm in two and host cell assault against VAD porcine aortic valves in one case. Biopsies and explanted hearts: Twenty-four patients had a mean age of 53 years (range 38-68, S.D.=8.6). VADs were implanted for 177.8 days (range 7-593 days, S.D.=151.1). Comparison of histologic scores of biopsies with explanted hearts showed the following: CN 1.33 (S.D.=1.4)/0.21 (S.D.=0.66; P<.001); CB: 2.1 (S.D.=0.93)/0.83 (S.D.=0.28; NS); MC: 0.88 (S.D.=1.19)/0.13 (S.D.=0.34; P<.01); IE: 1.71 (S.D.=1.27)/0.38 (S.D.=0.65; NS); fibrosis: 1.08 (S.D.=1

Non-Exposure, Device-Assisted Endoscopic Full-thickness Resection.

Science.gov (United States)

Bauder, Markus; Schmidt, Arthur; Caca, Karel

2016-04-01

Recent developments have expanded the frontier of interventional endoscopy toward more extended resections following surgical principles. This article presents two new device-assisted techniques for endoscopic full-thickness resection in the upper and lower gastrointestinal tract. Both methods are nonexposure techniques avoiding exposure of gastrointestinal contents to the peritoneal cavity by a "close first-cut later" principle. The full-thickness resection device is a novel over-the-scope device designed for clip-assisted full-thickness resection of colorectal lesions. Endoscopic full-thickness resection of gastric subepithelial tumors can be performed after placing transmural sutures underneath the tumor with a suturing device originally designed for endoscopic antireflux therapy. Copyright © 2016 Elsevier Inc. All rights reserved.

Characteristics and outcome of patients with heart failure due to anabolic-androgenic steroids

DEFF Research Database (Denmark)

Søndergaard, Eva Bjerre; Thune, Jens Jakob; Gustafsson, Finn

2014-01-01

OBJECTIVES: The objective of the study was to analyse the outcome of patients with advanced heart failure due to abuse of anabolic-androgenic steroids. DESIGN: A retrospective chart review of patients admitted or referred for advanced heart failure, due to anabolic-androgenic steroid abuse...... with angiotensin-converting enzyme inhibitors and beta-blockers. The remaining 3 patients required implantation of a LV assist device (LVAD) and were listed for heart transplantation. No recovery of LV function in the patients treated with assist device was seen. CONCLUSION: Anabolic-androgenic steroid...

Repetitive use of levosimendan in advanced heart failure

DEFF Research Database (Denmark)

Poelzl, Gerhard; Altenberger, Johann; Baholli, Loant

2017-01-01

Patients in the latest stages of heart failure are severely compromised, with poor quality of life and frequent hospitalizations. Heart transplantation and left ventricular assist device implantation are viable options only for a minority, and intermittent or continuous infusions of positive...

Successful Implantation of a Left Ventricular Assist Device in a Patient with Heparin-Induced Thrombocytopenia and Thrombosis

Science.gov (United States)

Garland, Cassandra; Somogyi, David

2014-01-01

Abstract: We report the case of a 27-year-old woman with signs of heparin-induced thrombocytopenia and thrombosis (HITT) and left heart failure presenting for urgent implantation of a left ventricular assist device (LVAD). HITT can occur in 4.2–6.1% of patients with LVADs. If the patient remains hemodynamically stable, implantation can be delayed for several months until the heparin/PF-4 antibodies decline allowing the use of heparin on cardiopulmonary bypass, However, in most cases related to cardiogenic shock, surgery cannot be delayed. We present the case of a patient who underwent implantation of a HeartMate II LVAD and discuss management strategy using bivalirudin during cardiopulmonary bypass. PMID:25208434

Impact of long term left ventricular assist device therapy on donor allocation in cardiac transplantation.

Science.gov (United States)

Uriel, Nir; Jorde, Ulrich P; Woo Pak, Sang; Jiang, Jeff; Clerkin, Kevin; Takayama, Hiroo; Naka, Yoshifumi; Schulze, P Christian; Mancini, Donna M

2013-02-01

Left Ventricular Assist Devices (LVAD) are increasingly used as a bridge to transplant (BTT) for patients with advanced congestive heart failure (CHF) and are assigned United Network for Organ Sharing (UNOS) high priority status (1B or 1A). The purpose of our study was asses the effect of organ allocation in the era of continuous flow pumps. A retrospective chart review was performed of all patients transplanted between 1/2001-1/2011 at Columbia University Medical Center. Seven hundred twenty six adult heart transplantations were performed. Two hundred seventy four BTT patients were implanted with LVAD; of which 227 patients were transplanted. Sixty three patients were transplanted as UNOS-1B, while 164 were transplanted as UNOS-1A (72%). Of these 164 patients, 65 were transplanted during their 30-day 1A period (43%) and 96 after upgrading to UNOS-1A for device complication (56%). For 452 non-device patients 139 (31%) were transplanted as UNOS-1A, 233 as UNOS-1B (52%), and 80 as UNOS-2 (17%). The percentage of patients bridged with LVAD increased from 19% in 2001 to 64% in 2010 while the number transplanted during their 30 day 1A grace period declined from 57% in 2005 to 16% in 2011; i.e. 84% of BTT patients in 2011 needed more than 30 days 1A time to be transplanted. Most LVAD patients are now transplanted while suffering device complication. There was no difference in post transplant survival between LVAD patients transplanted as UNOS 1B, 1A grace period or for a device complication As wait time for cardiac transplantation increased the percentage of patients being bridged to transplant with an LVAD has increased with the majority of them transplanted in the setting of device complication. Copyright © 2013 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

The total artificial heart.

Science.gov (United States)

Cook, Jason A; Shah, Keyur B; Quader, Mohammed A; Cooke, Richard H; Kasirajan, Vigneshwar; Rao, Kris K; Smallfield, Melissa C; Tchoukina, Inna; Tang, Daniel G

2015-12-01

The total artificial heart (TAH) is a form of mechanical circulatory support in which the patient's native ventricles and valves are explanted and replaced by a pneumatically powered artificial heart. Currently, the TAH is approved for use in end-stage biventricular heart failure as a bridge to heart transplantation. However, with an increasing global burden of cardiovascular disease and congestive heart failure, the number of patients with end-stage heart failure awaiting heart transplantation now far exceeds the number of available hearts. As a result, the use of mechanical circulatory support, including the TAH and left ventricular assist device (LVAD), is growing exponentially. The LVAD is already widely used as destination therapy, and destination therapy for the TAH is under investigation. While most patients requiring mechanical circulatory support are effectively treated with LVADs, there is a subset of patients with concurrent right ventricular failure or major structural barriers to LVAD placement in whom TAH may be more appropriate. The history, indications, surgical implantation, post device management, outcomes, complications, and future direction of the TAH are discussed in this review.

Computer-assisted instruction; MR imaging of congenital heart disease

International Nuclear Information System (INIS)

Choi, Young Hi; Yu, Pil Mun; Lee, Sang Hoon; Choe, Yeon Hyeon; Kim, Yang Min

1996-01-01

To develop a software program for computer-assisted instruction on MR imaging of congenital heart disease for medical students and residents to achieve repetitive and effective self-learning. We used a film scanner(Scan Maker 35t) and IBM-PC(486 DX-2, 60 MHz) for acquisition and storage of image data. The accessories attached to the main processor were CD-ROM drive(Sony), sound card(Soundblaster-Pro), and speaker. We used software of Adobe Photoshop(v 3.0) and paint shop-pro(v 3.0) for preprocessing image data, and paintbrush from microsoft windows 3.1 for labelling. The language used for programming was visual basic(v 3.0) from microsoft corporation. We developed a software program for computer-assisted instruction on MR imaging of congenital heart disease as an effective educational tool

Extracorporeal total artificial heart as bailout surgery.

Science.gov (United States)

Perrodin, Stéphanie F; Muller, Olivier; Gronchi, Fabrizio; Liaudet, Lucas; Hullin, Roger; Kirsch, Matthias

2017-03-01

We report the use of a total extracorporeal heart for uncontrolled bleeding following a proximal left anterior descending artery perforation, using two centrifugal ventricular assist devices after heart explantation. The literature describing similar techniques and patient outcomes for this "bailout" technique are reviewed. © 2017 Wiley Periodicals, Inc.

Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure -1 year results from the Ce mark trial.

Science.gov (United States)

Krabatsch, Thomas; Netuka, Ivan; Schmitto, Jan D; Zimpfer, Daniel; Garbade, Jens; Rao, Vivek; Morshuis, Michiel; Beyersdorf, Friedhelm; Marasco, Silvana; Damme, Laura; Pya, Yuriy

2017-04-04

The HeartMate 3 Left Ventricular Assist System (LVAS) (St. Jude Medical Inc., St Paul, MN) with full magnetic levitation allows for wide and consistent blood flow paths and an artificial pulse designed for enhanced hemocompatibility. The HeartMate 3 received market approval in the European Union in 2015 following completion of a multicenter study. After reaching the 6-month study endpoint, patients continue to be followed for 2 years with the 1-year results presented herein. A prospective, non-randomized study included adults with advanced heart failure and ejection fraction (EF) ≤ 25%, cardiac index (CI) ≤ 2.2 L/min/m2 while not on inotropes, or inotrope dependent, or on optimal medical management for 45/60 days. Fifty patients-54% bridge to transplant (BTT) and 46% destination therapy (DT)-were enrolled and implanted with the HeartMate 3. At baseline, 92% of the patients were INTERMACS profiles 2-4, with cardiac index 1.8 + 0.5 L/min/m 2 and 58% were supported with inotropes. At 1 year, 74% of the patients remain on support, 18% expired, 6% transplanted, and 2% explanted. The adverse events include 12% gastrointestinal bleeding, 16% driveline infections, 18% strokes, and 2% outflow graft thrombosis. There was no hemolysis, pump thrombosis or pump malfunction through 1 year. The six-minute walk test distance increased from a mean of 273 m to 371 m (P <0.0001). EQ-5D quality-of-life score increased from a mean of 52.7 to 70.8 (P = 0.0006). The 1-year HeartMate 3 LVAS results show survival and adverse-event profile are similar to other approved devices, with no pump thrombosis or pump failure. Patient's functional status and quality of life significantly improved over time. Clinicaltrials.gov registration number: NCT02170363 . Registered June 19, 2014.

Heart Motion Prediction in Robotic-Assisted Beating Heart Surgery: A Nonlinear Fast Adaptive Approach

Directory of Open Access Journals (Sweden)

Fan Liang

2013-01-01

Full Text Available Off-pump Coronary Artery Bypass Graft (CABG surgery outperforms traditional on-pump surgery because the assisted robotic tools can alleviate the relative motion between the beating heart and robotic tools. Therefore, it is possible for the surgeon to operate on the beating heart and thus lessens post surgery complications for the patients. Due to the highly irregular and non-stationary nature of heart motion, it is critical that the beating heart motion is predicted in the model-based track control procedures. It is technically preferable to model heart motion in a nonlinear way because the characteristic analysis of 3D heart motion data through Bi-spectral analysis and Fourier methods demonstrates the involved nonlinearity of heart motion. We propose an adaptive nonlinear heart motion model based on the Volterra Series in this paper. We also design a fast lattice structure to achieve computational-efficiency for real-time online predictions. We argue that the quadratic term of the Volterra Series can improve the prediction accuracy by covering sharp change points and including the motion with sufficient detail. The experiment results indicate that the adaptive nonlinear heart motion prediction algorithm outperforms the autoregressive (AR and the time-varying Fourier-series models in terms of the root mean square of the prediction error and the prediction error in extreme cases.

The influence of device position on the flow within the Penn State 12 cc pediatric ventricular assist device.

Science.gov (United States)

Schönberger, Markus; Deutsch, Steven; Manning, Keefe B

2012-01-01

Ventricular assist devices are a commonly used heart failure therapy for adult patients as bridge-to-transplant or bridge-to-recovery tools. The application of adult ventricular assist devices in pediatric patients has led to increased thrombotic events. Therefore, we have been developing a pediatric ventricular assist device (PVAD), the Penn State 12 cc PVAD. It is designed for patients with a body weight of 5-15 kg and has a stroke volume of 12 cc. Clot formation is the major concern. It is correlated to the coagulability of blood, the blood contacting materials and the fluid dynamics within the system. The intent is for the PVAD to be a long term therapy. Therefore, the system may be oriented in different positions according to the patient's behavior. This study evaluates for the first time the impact of position on the flow patterns within the Penn State 12 cc PVAD, which may help to improve the PVAD design concerning chamber and ports geometries. The fluid dynamics are visualized by particle image velocimetry. The evaluation is based on inlet jet behavior and calculated wall shear rates. Vertical and horizontal model orientations are compared, both with a beat rate of 75, outlet pressures of 90/60 mm Hg and a flow rate of 1.3 l/min. The results show a significant change of the inlet jet behavior and the development of a rotational flow pattern. Vertically, the inlet jet is strong along the wall. It initiates a rotational flow pattern with a wandering axis of rotation. In contrast, the horizontal model orientation results show a weaker inlet jet along the wall with a nearly constant center of rotation location, which can be correlated to a higher risk of thrombotic events. In addition, high speed videography illustrates differences in the diaphragm motion during diastole. Diaphragm opening trajectories measurements determine no significant impact of the density of the blood analog fluids. Hence, the results correlate to human blood.

Analysis of Contemporary Methods for Designing Rotary Type Ventricular Assist Devices

Directory of Open Access Journals (Sweden)

E. P. Banin

2015-01-01

Full Text Available The research object is inlet apparatus of ventricular assist device, namely inlet cannula and straightener.The purpose of the study is to reveal features of blood flow in inlet apparatus of ventricular assist device. The mathematical modeling is carried out by computational fluid dynamics analysis in a stationary setting.The first part of study concerns the analysis of existing approaches to the numerical and experimental studies in designing the ventricular assist devices of rotary type. It reveals the features of each approach for their further application in practice. The article presents an original design of developed hydraulic test bench to verify the results of mathematical modeling. Analysis of foreign authors’ studies showed that there is no enough attention paid to design of the adjacent pump assemblies of ventricular assist device. The second part of study considers direct mathematical modeling of input apparatus of ventricular assist device. The study examined straightener with three or four blades. Mathematical modeling has revealed the presence of potentially dangerous stagnation zones and essential asymmetry of the outlet flow from the input unit. The found features must be taken in consideration in designing the ventricular assist device pumps. In the future we plan to use obtained data to create a parametric model of the rotor and the diffuser considering the abovementioned features.

Evolution of general surgical problems in patients with left ventricular assist devices.

Science.gov (United States)

McKellar, Stephen H; Morris, David S; Mauermann, William J; Park, Soon J; Zietlow, Scott P

2012-11-01

Left ventricular assist devices (LVADs) are increasingly used to treat patients with end-stage heart failure. These patients may develop acute noncardiac surgical problems around the time of LVAD implantation or, as survival continues to improve, chronic surgical problems as ambulatory patients remote from the LVAD implant. Previous reports of noncardiac surgical problems in LVAD patients included patients with older, first-generation devices and do not address newer, second-generation devices. We describe the frequency and management of noncardiac surgical problems encountered during LVAD support with these newer-generation devices to assist noncardiac surgeons involved in the care of patients with LVADs. We retrospectively reviewed the medical records of consecutive patients receiving LVADs at our institution. We collected data for any consultation by noncardiac surgeons within the scope of general surgery during LVAD support and subsequent treatment. Ninety-nine patients received implantable LVADs between 2003 and 2009 (first-generation, n = 19; second-generation, n = 80). Excluding intestinal hemorrhage, general surgical opinions were rendered for 34 patients with 49 problems, mostly in the acute recovery phase after LVAD implantation. Of those, 27 patients underwent 28 operations. Respiratory failure and intra-abdominal pathologies were the most common problems addressed, and LVAD rarely precluded operation. Patients with second-generation LVADs were more likely to survive hospitalization (P = .04) and develop chronic, rather than emergent, surgical problems. Patients with LVADs frequently require consultation from noncardiac surgeons within the scope of general surgeons and often require operation. Patients with second-generation LVADs are more likely to become outpatients and develop more elective surgical problems. Noncardiac surgeons will be increasingly involved in caring for patients with LVADs and should anticipate the problems unique to this patient

Evaluation of Automated Flagger Assistance Devices

Science.gov (United States)

2018-02-01

Automated flagger assistance devices (AFADs) are designed to improve worker safety by replacing flaggers who are typically located near traffic approaching a work zone. In this study, a new AFAD developed by the Missouri Department of Transportation ...

Pump speed modulations and sub-maximal exercise tolerance in left ventricular assist device recipients

DEFF Research Database (Denmark)

Jung, Mette Holme; Houston, Brian; Russell, Stuart D

2017-01-01

of the 2 sub-maximal tests was determined by randomization. Both patient and physician were blinded to the sequence. Exercise duration, oxygen consumption (VO2) and rate of perceived exertion (RPE), using the Borg scale (score 6 to 20), were recorded. RESULTS: Nineteen patients (all with a HeartMate II...... ventricular assist device) completed 57 exercise tests. Baseline pump speed was 9,326 ± 378 rpm. At AT, workload was 63 ± 26 W (25 to 115 W) and VO2 was 79 ± 14% of maximum. Exercise duration improved by 106 ± 217 seconds (~13%) in Speedinc compared with Speedbase (837 ± 358 vs 942 ± 359 seconds; p = 0...

Continuous flow left ventricular assist devices: shared care goals of monitoring and treating patients.

Science.gov (United States)

Estep, Jerry D; Trachtenberg, Barry H; Loza, Laurie P; Bruckner, Brian A

2015-01-01

Continuous-flow left ventricular assist devices (CF-LVADs) have been clinically adopted as a long-term standard of care therapy option for patients with end-stage heart failure. For many patients, shared care between the care providers at the implanting center and care providers in the community in which the patient resides is a clinical necessity. The aims of this review are to (1) provide a rationale for the outpatient follow-up exam and surveillance testing used at our center to monitor patients supported by the HeartMate II(®) CF-LVAD (Thoratec Corporation, Pleasanton, CA) and (2) provide the protocol/algorithms we use for blood pressure, driveline exit site, LVAD alarm history, surveillance blood work, and echocardiography monitoring in this patient population. In addition, we define our partnership outpatient follow-up protocol and the "shared care" specific responsibilities we use with referring health care providers to best manage many of our patients.

Exercise Capacity and Functional Performance in Heart Failure Patients Supported by a Left Ventricular Assist Device at Discharge From Inpatient Rehabilitation.

Science.gov (United States)

Schmidt, Thomas; Bjarnason-Wehrens, Birna; Bartsch, Petra; Deniz, Ezin; Schmitto, Jan; Schulte-Eistrup, Sebastian; Willemsen, Detlev; Reiss, Nils

2018-01-01

Adequate physical and functional performance is an important prerequisite for renewed participation and integration in self-determined private and (where appropriate) professional lives following left ventricular assist device (LVAD) implantation. During cardiac rehabilitation (CR), individually adapted exercise programs aim to increase exercise capacity and functional performance. A retrospective analysis of cardiopulmonary exercise capacity and functional performance in LVAD patients at discharge from a cardiac rehabilitation program was conducted. The results from 68 LVAD patients (59 males, 9 females; 55.9 ± 11.7 years; 47 HVAD, 2 MVAD, 15 HeartMate II, 4 HeartMate 3, and 4 different implanting centers) were included in the analysis. Exercise capacity was assessed using a cardiopulmonary exercise test on a bicycle ergometer (ramp protocol; 10 W/min). The 6-min walk test was used to determine functional performance. At discharge from CR (53 ± 17 days after implantation), the mean peak work load achieved was 62.2 ± 19.3 W (38% of predicted values) or 0.79 ± 0.25 W/kg body weight. The mean cardiopulmonary exercise capacity (relative peak oxygen uptake) was 10.6 ± 5.3 mL/kg/min (37% of predicted values). The 6-min walk distance improved significantly during CR (325 ± 106 to 405 ± 77 m; P exercise capacity remains considerably restricted. In contrast, functional performance, measured by the 6-min walk distance, reaches an acceptable level. Light everyday tasks seem to be realistically surmountable for patients, making discharge from inpatient rehabilitation possible. Long-term monitoring is required in order to evaluate the situation and how it develops further. © 2017 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Carotid Doppler ultrasound findings in patients with left ventricular assist devices.

Science.gov (United States)

Cervini, Patrick; Park, Soon J; Shah, Dipesh K; Penev, Irina E; Lewis, Bradley D

2010-12-01

Left ventricular assist devices (LVADs) have been used to treat advanced heart failure refractory to medical management, as bridge therapy to myocardial recovery, as bridge therapy to cardiac transplantation, or as destination therapy for patients with unfavorable transplant candidacy. Neurologic complications are some of the most common and devastating complications in these patients. Preoperative carotid ultrasound is, therefore, a standard evaluation in patients at risk for cerebrovascular disease. Postoperative carotid artery Doppler sonography is performed in those patients with neurologic symptoms. It is likely, therefore, that sonographers, radiologists, and other physicians working in a center where LVADs are implanted will likely encounter a carotid artery Doppler study in this patient group. To our knowledge, the carotid Doppler findings in these patients have never been published. We review the Doppler ultrasound findings in 6 patients after LVAD insertion.

A novel implantable electromechanical ventricular assist device - First acute animal testing

NARCIS (Netherlands)

Kaufmann, R; Rakhorst, G; Mihaylov, D; Elstrodt, J; Nix, C; Reul, H; Rau, G

1997-01-01

A novel ventricular assist device (HIA-EMLVAD-AT1, Helmholtz Institute Aachen-electromechanical Left Ventricular Assist Device-Animal Test Version 1), driven by a uniformly and unidirectionally rotating actuator and a patented hypocycloidic pusherplate displacement gear unit, was developed and

Neurohormonal activation and exercise tolerance in patients supported with a continuous-flow left ventricular assist device

DEFF Research Database (Denmark)

Jung, Mette Holme; Goetze, Jens Peter; Boesgaard, Soeren

2016-01-01

BACKGROUND: Neurohormones play a key role in regulating hemodynamics in heart failure (HF) both at rest and during exercise. In contrast, little is known about the importance of neurohormonal regulation for exercise capacity in continuous-flow left ventricular assist device (CF-LVAD) patients....... The aim of this study was to assess the relation between neurohormonal activation patterns in CF-LVAD patients and exercise capacity. METHODS: Plasma concentrations of the C-terminal portion of pro-arginine vasopressin precursor (copeptin), pro-adrenomedullin (proADM), pro-B-type (proBNP) and pro......-atrial (proANP) natriuretic peptides were measured in 25 CF-LVAD patients (HeartMate II) in the morning prior to maximal cardiopulmonary exercise testing determining peak oxygen uptake (peak VO2). Quality of life (QOL) was determined by questionnaires. RESULTS: Peak VO2 was severely reduced averaging 13...

Left thoracotomy HeartWare implantation with outflow graft anastomosis to the descending aorta: a simplified bridge for patients with multiple previous sternotomies.

Science.gov (United States)

Umakanthan, Ramanan; Haglund, Nicholas A; Stulak, John M; Joyce, Lyle D; Ahmad, Rashid; Keebler, Mary E; Maltais, Simon

2013-01-01

Advances in mechanical circulatory support have been critical in bridging patients awaiting heart transplantation. In addition, improvement in device durability has enabled left ventricular assist device therapy to be applied as destination therapy in those not felt to be transplant candidate. Because of the increasing complexity of patients, there continues to be a need for alternative strategies for device implantation to bridge high-risk patients awaiting heart transplantation, wherein the risks of numerous previous sternotomies may be prohibitive. We present a unique technique for placement of the HeartWare ventricular assist device via left anterior thoracotomy to the descending aorta in a patient awaiting heart transplantation with a history of multiple previous sternotomies.

Stroke Risk and Mortality in Patients With Ventricular Assist Devices.

Science.gov (United States)

Parikh, Neal S; Cool, Joséphine; Karas, Maria G; Boehme, Amelia K; Kamel, Hooman

2016-11-01

Ventricular assist devices (VADs) have advanced the management of end-stage heart failure. However, these devices are associated with hemorrhagic and thrombotic complications, including stroke. We assessed the incidence, risk factors, and outcomes of ischemic and hemorrhagic stroke after VAD placement. Using administrative claims data from acute care hospitals in California, Florida, and New York from 2005 to 2013, we identified patients who underwent VAD placement, defined by the International Classification of Diseases, Ninth Revision, Clinical Modification code 37.66. Ischemic and hemorrhagic strokes were identified by previously validated coding algorithms. We used survival statistics to determine the incidence rates and Cox proportional hazard analyses to examine the associations. Among 1813 patients, we identified 201 ischemic strokes and 116 hemorrhagic strokes during 3.4 (±2.0) years of follow-up after implantation of a VAD. The incidence of stroke was 8.7% per year (95% confidence interval [CI], 7.7-9.7). The annual incidence of ischemic stroke (5.5%; 95% CI, 4.8-6.4) was nearly double that of hemorrhagic stroke (3.1%; 95% CI, 2.6-3.8). Women faced a higher hazard of stroke than men (hazard ratio, 1.6; 95% CI, 1.2-2.1), particularly hemorrhagic stroke (hazard ratio, 2.2; 95% CI, 1.4-3.4). Stroke was strongly associated with subsequent in-hospital mortality (hazard ratio, 6.1; 95% CI, 4.6-7.9). The incidence of stroke after VAD implantation was 8.7% per year, and incident stroke was strongly associated with subsequent in-hospital mortality. Notably, ischemic stroke occurred at nearly twice the rate of hemorrhagic stroke. Women seemed to face a higher risk for hemorrhagic stroke than men. © 2016 American Heart Association, Inc.

A difficult decision: what should we do when malignant tumours are diagnosed in patients supported by left ventricular assist devices?

Science.gov (United States)

Smail, Hassiba; Pfister, Christian; Baste, Jean-Marc; Nafeh-Bizet, Catherine; Gay, Arnaud; Barbay, Virginie; Bessou, Jean-Paul; Peillon, Christophe; Litzler, Pierre-Yves

2015-09-01

Left ventricular assist devices (LVADs) are used as a bridge to heart transplantation. During the preimplantation or pretransplantation screening, malignant tumours can be discovered. Owing to the lack of guidelines, the management is difficult. We describe our perioperative approach and the patients' outcomes. Between 2006 and 2014, 55 patients underwent implantation of HeartMate II LVAD. Five were diagnosed with malignant tumours: 2 renal, 2 lung and 1 breast tumours. The renal tumours were diagnosed during the preimplantation screening. An LVAD was implanted in both followed by partial nephrectomies 8 and 9 months later. The lung cancers were diagnosed after device implantation, a left pulmonary segmentectomy and a right upper sleeve lobectomy were performed. The breast cancer was diagnosed few months after support and a tumourectomy with lymphadenectomy was performed. Tumour resection was performed successfully in all patients. Prior to surgery haemostasis, device and heart function were evaluated. During surgery, haemodynamics and anticoagulation were monitored. Reoperations were necessary to evacuate haemothorax after lobectomy and an abdominal haematoma post-nephrectomy. After discussion with oncologists, 3 patients were relisted for heart transplantation. Two were successfully transplanted 2 and 3 years after partial nephrectomy with an actual survival of 56 and 59 months after the cancer diagnosis. The follow-up revealed no cancer recurrences. Malignant tumours during support with LVAD can be successfully resected. A multidisciplinary evaluation in these high-risk patients is mandatory. After careful evaluation, regaining the patient's heart transplant candidacy is possible. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Perioperative Care of the Patient With the Total Artificial Heart.

Science.gov (United States)

Yaung, Jill; Arabia, Francisco A; Nurok, Michael

2017-05-01

Advanced heart failure continues to be a leading cause of morbidity and mortality despite improvements in pharmacologic therapy. High demand for cardiac transplantation and shortage of donor organs have led to an increase in the utilization of mechanical circulatory support devices. The total artificial heart is an effective biventricular assist device that may be used as a bridge to transplant and that is being studied for destination therapy. This review discusses the history, indications, and perioperative management of the total artificial heart with emphasis on the postoperative concerns.

Surgical approach to end-stage heart failure.

Science.gov (United States)

Klotz, Stefan; Scheld, Hans H

2011-02-01

End-stage heart failure is a challenging disease with growing incidence. With decreasing heart transplant rates worldwide organ preserving therapies become, again, of interest. The purpose of the present review is to examine the potential challenges of surgical therapies in patients with end-stage heart failure. The gold-standard for end-stage heart failure is and will be cardiac transplantation. However, due to organ shortage this therapy is limited to a few patients. Therefore implantation of ventricular assist devices (VADs) or long-term minimal-invasive partial support devices will increase. Improvements in device design with smaller devices, easier implantation techniques, and modified anticoagulation outcome and long-term success will likely improve. In addition, good quality of life as destination therapy is almost available. Organ conservation surgery (coronary artery bypass grafting and surgical ventricular restoration or surgical repair of mitral valve regurgitation) in end-stage heart failure patients could not prove the expected results. Transcatheter or minimal-invasive approaches of these therapies might become routine in the near future. Due to the overwhelming outcome rates, cardiac transplantation is the most established surgical therapy for end-stage heart failure. VAD therapy is increasing and minimized VADs might further open the market for destination therapy/permanent support.

2013 update on congenital heart disease, clinical cardiology, heart failure, and heart transplant.

Science.gov (United States)

Subirana, M Teresa; Barón-Esquivias, Gonzalo; Manito, Nicolás; Oliver, José M; Ripoll, Tomás; Lambert, Jose Luis; Zunzunegui, José L; Bover, Ramon; García-Pinilla, José Manuel

2014-03-01

This article presents the most relevant developments in 2013 in 3 key areas of cardiology: congenital heart disease, clinical cardiology, and heart failure and transplant. Within the area of congenital heart disease, we reviewed contributions related to sudden death in adult congenital heart disease, the importance of specific echocardiographic parameters in assessing the systemic right ventricle, problems in patients with repaired tetralogy of Fallot and indication for pulmonary valve replacement, and confirmation of the role of specific factors in the selection of candidates for Fontan surgery. The most recent publications in clinical cardiology include a study by a European working group on correct diagnostic work-up in cardiomyopathies, studies on the cost-effectiveness of percutaneous aortic valve implantation, a consensus document on the management of type B aortic dissection, and guidelines on aortic valve and ascending aortic disease. The most noteworthy developments in heart failure and transplantation include new American guidelines on heart failure, therapeutic advances in acute heart failure (serelaxin), the management of comorbidities such as iron deficiency, risk assessment using new biomarkers, and advances in ventricular assist devices. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

Total artificial heart in the pediatric patient with biventricular heart failure.

Science.gov (United States)

Park, S S; Sanders, D B; Smith, B P; Ryan, J; Plasencia, J; Osborn, M B; Wellnitz, C M; Southard, R N; Pierce, C N; Arabia, F A; Lane, J; Frakes, D; Velez, D A; Pophal, S G; Nigro, J J

2014-01-01

Mechanical circulatory support emerged for the pediatric population in the late 1980s as a bridge to cardiac transplantation. The Total Artificial Heart (TAH-t) (SynCardia Systems Inc., Tuscon, AZ) has been approved for compassionate use by the Food and Drug Administration for patients with end-stage biventricular heart failure as a bridge to heart transplantation since 1985 and has had FDA approval since 2004. However, of the 1,061 patients placed on the TAH-t, only 21 (2%) were under the age 18. SynCardia Systems, Inc. recommends a minimum patient body surface area (BSA) of 1.7 m(2), thus, limiting pediatric application of this device. This unique case report shares this pediatric institution's first experience with the TAH-t. A 14-year-old male was admitted with dilated cardiomyopathy and severe biventricular heart failure. The patient rapidly decompensated, requiring extracorporeal life support. An echocardiogram revealed severe biventricular dysfunction and diffuse clot formation in the left ventricle and outflow tract. The decision was made to transition to biventricular assist device. The biventricular failure and clot formation helped guide the team to the TAH-t, in spite of a BSA (1.5 m(2)) below the recommendation of 1.7 m(2). A computed tomography (CT) scan of the thorax, in conjunction with a novel three-dimensional (3D) modeling system and team, assisted in determining appropriate fit. Chest CT and 3D modeling following implantation were utilized to determine all major vascular structures were unobstructed and the bronchi were open. The virtual 3D model confirmed appropriate device fit with no evidence of compression to the left pulmonary veins. The postoperative course was complicated by a left lung opacification. The left lung anomalies proved to be atelectasis and improved with aggressive recruitment maneuvers. The patient was supported for 11 days prior to transplantation. Chest CT and 3D modeling were crucial in assessing whether the device would

Accurate diagnoses, evidence based drugs, and new devices (3 Ds in heart failure

Directory of Open Access Journals (Sweden)

Bambang B. Siswanto

2012-02-01

Full Text Available Heart failure becomes main problem in cardiology because of increasing of heart failure patients, rehospitalization rate, morbidity, and mortality rate. The main causes of increasing heart failure problems are: (1 Successful treatment of acute myocardial infarction can be life saving, but its sequelae can cause heart failure. (2 Increasing life expectancy rate grows along with incidences of ageing related heart failure. (3 High prevalence of infection in Indonesia can cause rheumatic heart disease post Streptococcal beta hemolyticus infection, viral myocarditis, infective endocartitis, and tuberculoid pericarditis. (4 Many risk factors for coronary heart disease are often found in heart failure patients, for examples smoking, diabetes, hypercholesterolemia, hypertension, and obesity. Indonesia joined international multicentered registry in 2006. Acute Decompensated HEart failure REgistry is a web based international registry to record patient with acute decompensated heart failure treated in emergency room. It was found that heart failure patients in 5 big hospitals in Java and Bali island that joined this registry are younger, sicker and late to seek treatment. The median hospital length of stay was 7 days and in hospital mortality rate was 6.7%. The aim of this article is to give summary about essential things in diagnosing and treating heart failure patients. 3D (accurate diagnoses, evidence based drugs, and new devices are the most important but what to do and what not to do in dealing with heart failure is also useful for your daily practice. (Med J Indones 2012;21:52-8Keywords: Devices, diagnostic, drugs, heart failure

Outcomes of patients with right ventricular failure on milrinone after left ventricular assist device implantation.

Science.gov (United States)

Tsiouris, Athanasios; Paone, Gaetano; Brewer, Robert J; Nemeh, Hassan W; Borgi, Jamil; Morgan, Jeffrey A

2015-01-01

Previous studies have grouped together both patients requiring right ventricular assist devices (RVADs) with patients requiring prolonged milrinone therapy after left ventricular assist device (LVAD) implantation. We retrospectively identified 149 patients receiving LVADs and 18 (12.1%) of which developed right ventricular (RV) failure. We then separated these patients into those requiring RVADs versus prolonged milrinone therapy. This included 10 patients who were treated with prolonged milrinone and eight patients who underwent RVAD placement. Overall, the RV failure group had worse survival compared with the non-RV failure cohort (p = 0.038). However, this was only for the subgroup of patients who required RVADs, who had a 1, 6, 12, and 24 month survival of 62.5%, 37.5%, 37.5%, and 37.5%, respectively, versus 96.8%, 92.1%, 86.7%, and 84.4% for patients without RV failure (p milrinone therapy for RV failure had similar survivals compared with patients without RV failure. In the RV failure group, age, preoperative renal failure, and previous cardiac surgery were predictors of the need for prolonged postoperative milrinone. As LVADs become a more widely used therapy for patients with refractory, end-stage heart failure, it will be important to reduce the incidence of RV failure, as it yields significant morbidity and increases cost.

Percutaneous Repair of Postoperative Mitral Regurgitation After Left Ventricular Assist Device Implant.

Science.gov (United States)

Cork, David P; Adamson, Robert; Gollapudi, Raghava; Dembitsky, Walter; Jaski, Brian

2018-02-01

Mitral regurgitation commonly improves after implantation of a left ventricular assist device without concomitant valvular repair owing to the mechanical unloading of the left ventricle. However, the development (or persistence) of significant mitral regurgitation after implantation of a left ventricular assist device is associated with adverse clinical events. We present a case of a left ventricular assist device patient who successfully underwent a percutaneous MitraClip procedure for repair of persistent late postoperative mitral insufficiency with demonstrable clinical and hemodynamic improvement. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

The effect of heart failure and left ventricular assist device treatment on right ventricular mechanics: a computational study.

Science.gov (United States)

Park, Jun I K; Heikhmakhtiar, Aulia Khamas; Kim, Chang Hyun; Kim, Yoo Seok; Choi, Seong Wook; Song, Kwang Soup; Lim, Ki Moo

2018-05-22

Although it is important to analyze the hemodynamic factors related to the right ventricle (RV) after left ventricular assist device (LVAD) implantation, previous studies have focused only on the alteration of the ventricular shape and lack quantitative analysis of the various hemodynamic parameters. Therefore, we quantitatively analyzed various hemodynamic parameters related to the RV under normal, heart failure (HF), and HF incorporated with continuous flow LVAD therapy by using a computational model. In this study, we combined a three-dimensional finite element electromechanical model of ventricles, which is based on human ventricular morphology captured by magnetic resonance imaging (MRI) with a lumped model of the circulatory system and continuous flow LVAD function in order to construct an integrated model of an LVAD implanted-cardiovascular system. To induce systolic dysfunction, the magnitude of the calcium transient function under HF condition was reduced to 70% of the normal value, and the time constant was reduced by 30% of the normal value. Under the HF condition, the left ventricular end systolic pressure decreased, the left ventricular end diastolic pressure increased, and the pressure in the right atrium (RA), RV, and pulmonary artery (PA) increased compared with the normal condition. The LVAD therapy decreased the end-systolic pressure of the LV by 41%, RA by 29%, RV by 53%, and PA by 71%, but increased the right ventricular ejection fraction by 52% and cardiac output by 40%, while the stroke work was reduced by 67% compared with the HF condition without LVAD. The end-systolic ventricular tension and strain decreased with the LVAD treatment. LVAD enhances CO and mechanical unloading of the LV as well as those of the RV and prevents pulmonary hypertension which can be induced by HF.

3D force control for robotic-assisted beating heart surgery based on viscoelastic tissue model.

Science.gov (United States)

Liu, Chao; Moreira, Pedro; Zemiti, Nabil; Poignet, Philippe

2011-01-01

Current cardiac surgery faces the challenging problem of heart beating motion even with the help of mechanical stabilizer which makes delicate operation on the heart surface difficult. Motion compensation methods for robotic-assisted beating heart surgery have been proposed recently in literature, but research on force control for such kind of surgery has hardly been reported. Moreover, the viscoelasticity property of the interaction between organ tissue and robotic instrument further complicates the force control design which is much easier in other applications by assuming the interaction model to be elastic (industry, stiff object manipulation, etc.). In this work, we present a three-dimensional force control method for robotic-assisted beating heart surgery taking into consideration of the viscoelastic interaction property. Performance studies based on our D2M2 robot and 3D heart beating motion information obtained through Da Vinci™ system are provided.

78 FR 34922 - Definition of Auditory Assistance Device

Science.gov (United States)

2013-06-11

... permitting such use of these devices would increase the comprehension of persons that need language... communications (including but not limited to applications such as assistive listening, auricular training, audio...

Modification of a Volume-Overload Heart Failure Model to Track Myocardial Remodeling and Device-Related Reverse Remodeling

Science.gov (United States)

Tuzun, Egemen; Bick, Roger; Kadipasaoglu, Cihan; Conger, Jeffrey L.; Poindexter, Brian J.; Gregoric, Igor D.; Frazier, O. H.; Towbin, Jeffrey A.; Radovancevic, Branislav

2011-01-01

Purpose. To provide an ovine model of ventricular remodeling and reverse remodeling by creating congestive heart failure (CHF) and then treating it by implanting a left ventricular assist device (LVAD). Methods. We induced volume-overload heart failure in 2 sheep; 20 weeks later, we implanted an LVAD and assessed recovery 11 weeks thereafter. We examined changes in histologic and hemodynamic data and levels of cellular markers of CHF. Results. After CHF induction, we found increases in LV end-diastolic pressure, LV systolic and diastolic dimensions, wall thickness, left atrial diameter, and atrial natriuretic protein (ANP) and endothelin-1 (ET-1) levels; β-adrenergic receptor (BAR) and dystrophin expression decreased markedly. Biopsies confirmed LV remodeling. After LVAD support, LV systolic and diastolic dimensions, wall thickness, and mass, and ANP and ET-1 levels decreased. Histopathologic and hemodynamic markers improved, and BAR and dystrophin expression normalized. Conclusions. We describe a successful sheep model for ventricular and reverse remodeling. PMID:22347659

Synergy of first principles modelling with predictive control for a biventricular assist device: In silico evaluation study.

Science.gov (United States)

Koh, Vivian C A; Yong Kuen Ho; Stevens, Michael C; Salamonsen, Robert F; Lovell, Nigel H; Lim, Einly

2017-07-01

Control for dual rotary left ventricular assist devices (LVADs) used as a biventricular assist device (BiVAD) is challenging. If the control system fails, flow imbalance between the systemic and the pulmonary circulations would result, subsequently leading to ventricular suction or pulmonary congestion. With the expectation that advanced control approaches such as model predictive control could address the challenges naturally and effectively, we developed a synergistic first principles model predictive controller (MPC) for the BiVAD. The internal model of the MPC is a simplified state-space model that has been developed and validated in a previous study. A single Frank-Starling (FS) control curve was used to define the target pump flow corresponding to the preload on each side of the heart. The MPC was evaluated in a validated numerical model using three clinical scenarios: blood loss, myocardial recovery, and exercise. Simulation results showed that the MPC was effective in adapting to changes in physiological states without causing ventricular suction or pulmonary congestion. The use of MPC for a BiVAD eliminates the need for two controllers of dual LVADs thus making the task of controller tuning easier.

Assistive acting movement therapy devices with pneumatic rotary-type soft actuators.

Science.gov (United States)

Wilkening, André; Baiden, David; Ivlev, Oleg

2012-12-01

Inherent compliance and assistive behavior are assumed to be essential properties for safe human-robot interaction. Rehabilitation robots demand the highest standards in this respect because the machine interacts directly with weak persons who are often sensitive to pain. Using novel soft fluidic actuators with rotary elastic chambers (REC actuators), compact, lightweight, and cost-effective therapeutic devices can be developed. This article describes modular design and control strategies for new assistive acting robotic devices for upper and lower extremities. Due to the inherent compliance and natural back-drivability of pneumatic REC actuators, these movement therapy devices provide gentle treatment, whereby the interaction forces between humans and the therapy device are estimated without the use of expensive force/torque sensors. An active model-based gravity compensation based on separated models of the robot and of the individual patient's extremity provides the basis for effective assistive control. The utilization of pneumatic actuators demands a special safety concept, which is merged with control algorithms to provide a sufficient level of safeness and to catch any possible system errors and/or emergency situations. A self-explanatory user interface allows for easy, intuitive handling. Prototypes are very comfortable for use due to several control routines that work in the background. Assistive devices have been tested extensively with several healthy persons; the knee/hip movement therapy device is now under clinical trials at the Clinic for Orthopaedics and Trauma Surgery at the Klinikum Stuttgart.

[Artificial muscle and its prospect in application for direct cardiac compression assist].

Science.gov (United States)

Dong, Jing; Yang, Ming; Zheng, Zhejun; Yan, Guozheng

2008-12-01

Artificial heart is an effective device in solving insufficient native heart supply for heart transplant, and the research and application of novel actuators play an important role in the development of artificial heart. In this paper, artificial muscle is introduced as the actuators of direct cardiac compression assist, and some of its parameters are compared with those of native heart muscle. The open problems are also discussed.

German disease management guidelines: surgical therapies for chronic heart failure.

Science.gov (United States)

Sindermann, J R; Klotz, S; Rahbar, K; Hoffmeier, A; Drees, G

2010-02-01

The German Disease Management Guideline "Chronic Heart Failure" intends to guide physicians working in the field of diagnosis and treatment of heart failure. The guideline provides a tool on the background of evidence based medicine. The following short review wants to give insights into the role of some surgical treatment options to improve heart failure, such as revascularization, ventricular reconstruction and aneurysmectomy, mitral valve reconstruction, ventricular assist devices and heart transplantation. (c) Georg Thieme Verlag KG Stuttgart-New York.

Predictors of survival and ability to wean from short-term mechanical circulatory support device following acute myocardial infarction complicated by cardiogenic shock.

Science.gov (United States)

Garan, A Reshad; Eckhardt, Christina; Takeda, Koji; Topkara, Veli K; Clerkin, Kevin; Fried, Justin; Masoumi, Amirali; Demmer, Ryan T; Trinh, Pauline; Yuzefpolskaya, Melana; Naka, Yoshifumi; Burkhoff, Dan; Kirtane, Ajay; Colombo, Paolo C; Takayama, Hiroo

2017-11-01

Cardiogenic shock following acute myocardial infarction (AMI-CS) portends a poor prognosis. Short-term mechanical circulatory support devices (MCSDs) provide hemodynamic support for patients with cardiogenic shock but predictors of survival and the ability to wean from short-term MCSDs remain largely unknown. All patients > 18 years old treated at our institution with extra-corporeal membrane oxygenation or short-term surgical ventricular assist device for AMI-CS were studied. We collected acute myocardial infarction details with demographic and hemodynamic variables. Primary outcomes were survival to discharge and recovery from MCSD (i.e. survival without heart replacement therapy including durable ventricular assist device or heart transplant). One hundred and twenty-four patients received extra-corporeal membrane oxygenation or short-term surgical ventricular assist device following acute myocardial infarction from 2007 to 2016; 89 received extra-corporeal membrane oxygenation and 35 short-term ventricular assist device. Fifty-five (44.4%) died in the hospital and 69 (55.6%) survived to discharge. Twenty-six (37.7%) required heart replacement therapy (four transplant, 22 durable ventricular assist device) and 43 (62.3%) were discharged without heart replacement therapy. Age and cardiac index at MCSD implantation were predictors of survival to discharge; patients over 60 years with cardiac index <1.5 l/min per m 2 had a low likelihood of survival. The angiographic result after revascularization predicted recovery from MCSD (odds ratio 9.00, 95% confidence interval 2.45-32.99, p=0.001), but 50% of those optimally revascularized still required heart replacement therapy. Cardiac index predicted recovery from MCSD among this group (odds ratio 4.06, 95% confidence interval 1.45-11.55, p=0.009). Among AMI-CS patients requiring short-term MCSDs, age and cardiac index predict survival to discharge. Angiographic result and cardiac index predict ventricular recovery but 50

The Total Artificial Heart in End-Stage Congenital Heart Disease.

Science.gov (United States)

Villa, Chet R; Morales, David L S

2017-01-01

The development of durable ventricular assist devices (VADs) has improved mortality rates and quality of life in patients with end stage heart failure. While the use of VADs has increased dramatically in recent years, there is limited experience with VAD implantation in patients with complex congenital heart disease (CHD), despite the fact that the number of patients with end stage CHD has grown due to improvements in surgical and medical care. VAD use has been limited in patients with CHD and end stage heart failure due to anatomic (systemic right ventricle, single ventricle, surgically altered anatomy, valve dysfunction, etc.) and physiologic constraints (diastolic dysfunction). The total artificial heart (TAH), which has right and left sided pumps that can be arranged in a variety of orientations, can accommodate the anatomic variation present in CHD patients. This review provides an overview of the potential use of the TAH in patients with CHD.

Wave Intensity Analysis of Right Ventricular Function during Pulsed Operation of Rotary Left Ventricular Assist Devices.

Science.gov (United States)

Bouwmeester, J Christopher; Park, Jiheum; Valdovinos, John; Bonde, Pramod

2018-05-29

Changing the speed of left ventricular assist devices (LVADs) cyclically may be useful to restore aortic pulsatility; however, the effects of this pulsation on right ventricular (RV) function are unknown. This study investigates the effects of direct ventricular interaction by quantifying the amount of wave energy created by RV contraction when axial and centrifugal LVADs are used to assist the left ventricle. In 4 anesthetized pigs, pressure and flow were measured in the main pulmonary artery and wave intensity analysis was used to identify and quantify the energy of waves created by the RV. The axial pump depressed the intensity of waves created by RV contraction compared with the centrifugal pump. In both pump designs, there were only minor and variable differences between the continuous and pulsed operation on RV function. The axial pump causes the RV to contract with less energy compared with a centrifugal design. Diminishing the ability of the RV to produce less energy translates to less pressure and flow produced, which may lead to LVAD-induced RV failure. The effects of pulsed LVAD operation on the RV appear to be minimal during acute observation of healthy hearts. Further study is necessary to uncover the effects of other modes of speed modulation with healthy and unhealthy hearts to determine if pulsed operation will benefit patients by reducing LVAD complications.

Mycobacterium chimaera left ventricular assist device infections.

Science.gov (United States)

Balsam, Leora B; Louie, Eddie; Hill, Fred; Levine, Jamie; Phillips, Michael S

2017-06-01

A global outbreak of invasive Mycobacterium chimaera infections after cardiac surgery has recently been linked to bioaerosols from contaminated heater-cooler units. The majority of cases have occurred after valvular surgery or aortic graft surgery and nearly half have resulted in death. To date, infections in patients with left ventricular assist devices (LVADs) have not been characterized in the literature. We report two cases of device-associated M. chimaera infection in patients with continuous-flow LVADs and describe challenges related to diagnosis and management in this population. © 2017 Wiley Periodicals, Inc.

Advanced strategies for end-stage heart failure: combining regenerative approaches with LVAD, a new horizon?

Directory of Open Access Journals (Sweden)

Cheyenne eTseng

2015-04-01

Full Text Available Despite the improved treatment of cardiovascular diseases the population with end-stage heart failure is progressively growing. The scarcity of the gold standard therapy, heart transplantation, demands novel therapeutic approaches. For patients awaiting transplantation ventricular assist devices have been of great benefit on survival. To allow explantation of the assist device and obviate heart transplantation, sufficient and durable myocardial recovery is necessary. However, explant rates so far are low. Combining mechanical circulatory support with regenerative therapies such as cell(-based therapy and biomaterials might give rise to improved long-term results. Although synergistic effects are suggested with mechanical support and stem cell therapy, evidence in both preclinical and clinical setting is lacking. This review focuses on advanced and innovative strategies for the treatment of end-stage heart failure and furthermore appraises clinical experience with combined strategies.

Intraoperative Transesophageal Echocardiography and Right Ventricular Failure After Left Ventricular Assist Device Implantation.

Science.gov (United States)

Silverton, Natalie A; Patel, Ravi; Zimmerman, Josh; Ma, Jianing; Stoddard, Greg; Selzman, Craig; Morrissey, Candice K

2018-02-15

To determine whether intraoperative measures of right ventricular (RV) function using transesophageal echocardiography are associated with subsequent RV failure after left ventricular assist device (LVAD) implantation. Retrospective, nonrandomized, observational study. Single tertiary-level, university-affiliated hospital. The study comprised 100 patients with systolic heart failure undergoing elective LVAD implantation. Transesophageal echocardiographic images before and after cardiopulmonary bypass were analyzed to quantify RV function using tricuspid annular plane systolic excursion (TAPSE), tricuspid annular systolic velocity (S'), fractional area change (FAC), RV global longitudinal strain, and RV free wall strain. A chart review was performed to determine which patients subsequently developed RV failure (right ventricular assist device placement or prolonged inotrope requirement ≥14 days). Nineteen patients (19%) subsequently developed RV failure. Postbypass FAC was the only measure of RV function that distinguished between the RV failure and non-RV failure groups (21.2% v 26.5%; p = 0.04). The sensitivity, specificity, and area under the curve of an abnormal RV FAC (failure after LVAD implantation were 84%, 20%, and 0.52, respectively. No other intraoperative measure of RV function was associated with subsequent RV failure. RV failure increased ventilator time, intensive care unit and hospital length of stay, and mortality. Intraoperative measures of RV function such as tricuspid annular plane systolic excursion, tricuspid annular systolic velocity, and RV strain were not associated with RV failure after LVAD implantation. Decreased postbypass FAC was significantly associated with RV failure but showed poor discrimination. Copyright © 2018 Elsevier Inc. All rights reserved.

Peripheral Artery Disease and Continuous Flow Left Ventricle Assist Device: An Engaging Complement Analysis May Help to Guide Treatment.

Science.gov (United States)

Falletta, Calogero; Pasta, Salvatore; Raffa, Giuseppe Maria; Crinò, Francesca; Sciacca, Sergio; Clemenza, Francesco

2018-02-13

Use of continuous flow left ventricle assist device (CF-LVAD) in advanced heart failure (HF) patients results in clinically relevant improvements in survival, functional capacity, and quality of life. Peripheral artery disease (PAD) can occur in patients with CF-LVAD due to the high rate of concomitance between risk factors for atherosclerosis and HF. Diagnosis of PAD can be difficult in the specific setting of a patient supported by this kind of device because of the marked alteration in waveform morphology and velocity created by the artificial physiology of an LVAD. We report the case of a 53-year-old man with HF secondary to ischemic cardiomyopathy supported by the HeartWare HVAD as bridge to transplant, who after the implant developed symptoms suggestive of PAD. We describe additional computational flow analysis for the study of PAD-related hemodynamic disturbances induced by a CF-LVAD. Flow simulations enhance the information of clinical image data, and may have an application in clinical investigations of the risk of hemodynamic disturbances induced by LVAD implantation. © 2018 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Wireless patient monitoring system for a moving-actuator type artificial heart.

Science.gov (United States)

Nam, K W; Chung, J; Choi, S W; Sun, K; Min, B G

2006-10-01

In this study, we developed a wireless monitoring system for outpatients equipped with a moving-actuator type pulsatile bi-ventricular assist device, AnyHeart. The developed monitoring system consists of two parts; a Bluetooth-based short-distance self-monitoring system that can monitor and control the operating status of a VAD using a Bluetooth-embedded personal digital assistant or a personal computer within a distance of 10 meters, and a cellular network-based remote monitoring system that can continuously monitor and control the operating status of AnyHeart at any location. Results of in vitro experiments demonstrate the developed system's ability to monitor the operational status of an implanted AnyHeart.

New pharmacological and technological management strategies in heart failure

Directory of Open Access Journals (Sweden)

Chaudhry SP

2017-03-01

Full Text Available Sunit-Preet Chaudhry,1 Garrick C Stewart2 1Division of Cardiology, St Vincent Indianapolis, Indianapolis, IN, 2Division of Cardiovascular Medicine, Center for Advanced Heart Disease, Brigham and Women’s Hospital, Boston, MA, USA Abstract: Heart failure is a complex clinical syndrome resulting from impairment of ventricular filling or ejection of blood associated with symptoms of dyspnea, fatigue, as well as peripheral and/or pulmonary edema. This syndrome is progressive and characterized by worsening quality of life despite escalating levels of care, affecting 5.7 million Americans with an annual cost of over $30 billion US dollars. Treatment for this syndrome has evolved over three distinct eras: the nonpharmacological era, the pharmacological era, and the device era, with the focus shifting from symptomatic relief to decreasing morbidity and mortality. Over the past 10 years, the field has undergone a renaissance, with the development of new pharmacologic, hemodynamic monitoring, and device therapies proven to improve outcomes in patients with heart failure. This article will review several recent innovations in the management of patients with heart failure. Keywords: heart failure, heart-assist devices, disease management

Anesthesia for left ventricular assist device insertion: a case series and review.

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Broussard, David; Donaldson, Emilie; Falterman, Jason; Bates, Michael

2011-01-01

From October 2008 to June 2010, a total of 42 patients had the HeartMate II left ventricular assist device inserted surgically at Ochsner Medical Center in New Orleans, LA. A retrospective electronic record review was conducted on this series of patients to analyze elements of perioperative anesthetic care, including general anesthetic care, echocardiographic considerations, and blood product usage. Etomidate was used to induce anesthesia for 34 of 42 patients (81%) in this series, with an average dose of 16.5 mg (±6 mg). The average intraoperative fentanyl dose was 1,318 µg (±631 µg). On average, patients were extubated 91 hours (±72 hours) after arrival to the intensive care unit and left on day 9 (±5 days). The average left ventricular ejection fraction of the patients in this series was 13% (±5%). Sixteen patients were evaluated as having severe right-heart dysfunction preoperatively. Two of 42 patients required surgical closure of echocardiographically identified patent foramen ovale. Twelve of 42 patients underwent surgical correction of tricuspid regurgitation. On average, 3 units (±2.6 units) of fresh frozen plasma were transfused intraoperatively and 10 units postoperatively. Intraoperative red blood cell usage averaged 1.1 units (maximum, 7 units), with an average 9.3 units administered in the first 48 hours postoperatively.

Impact of tricuspid valve surgery at the time of left ventricular assist device insertion on postoperative outcomes.

Science.gov (United States)

Dunlay, Shannon M; Deo, Salil V; Park, Soon J

2015-01-01

Tricuspid regurgitation (TR) is common in patients with heart failure undergoing left ventricular assist device (LVAD) implantation. Whether the TR should be surgically managed at the time of LVAD surgery is controversial. We searched SCOPUS, Web of Science, Ovid EMBASE, and Ovid MEDLINE (through May 10, 2014) for randomized controlled trials and observational studies comparing postoperative outcomes in patients treated with LVAD with concomitant tricuspid valve surgery (TVS) compared with LVAD alone. Six observational studies including 3,249 patients compared outcomes following LVAD + TVS versus LVAD. Four studies were single-center and most did not adjust for potential confounders. Addition of TVS prolonged cardiopulmonary bypass times by an average of 31 minutes (three studies, 95% CI 20-42). There was no difference in need for right ventricular assist device (six studies, HR 1.42, 95% CI 0.54-3.76), acute renal failure (four studies, HR 1.07, 95% CI 0.55-2.10), or early mortality (six studies, HR 1.28, 95% CI 0.78-2.08) in patients treated with LVAD + TVS versus LVAD alone. TVS prolongs cardiopulmonary bypass times, but available data demonstrate no significant association with early postoperative outcomes. However, differences in baseline risk of patients treated with TVS versus not limit our ability to draw conclusions.

Assistive device use and mobility-related factors among adults aged≥65years.

Science.gov (United States)

West, Bethany A; Bhat, Geeta; Stevens, Judy; Bergen, Gwen

2015-12-01

Examining how assistive device (cane, walker) use relates to other mobility factors can provide insight into older adults' future mobility needs. Data come from the Second Injury Control and Risk Survey, Phase 2 (ICARIS2-P2), conducted from March 2007 to May 2008. Prevalence estimates were calculated for older adults (aged ≥65) and multivariable logistic regression was used to explore associations between assistive device use and mobility-related characteristics. Compared with non-users, assistive device users were more likely to report a recent fall (AOR 12.0; 95% CI 4.9-29.3), limit walking outside due to concerns about falling (AOR 7.1; 95% CI 2.6-19.1), be unable to walk outside for 10min without resting (AOR 3.3; 95% CI 1.1-9.3), and be no longer driving (AOR 6.7; 95% CI 2.0-22.3). Assistive device users have limited mobility and an increased risk for fall injury compared with non-users. Effective fall prevention interventions, and innovative transportation options, are needed to protect the mobility of this high-risk group. Published by Elsevier Ltd.

Durability of central aortic valve closure in patients with continuous flow left ventricular assist devices.

Science.gov (United States)

McKellar, Stephen H; Deo, Salil; Daly, Richard C; Durham, Lucian A; Joyce, Lyle D; Stulak, John M; Park, Soon J

2014-01-01

A competent aortic valve is essential to providing effective left ventricular assist device support. We have adopted a practice of central aortic valve closure by placing a simple coaptation stitch at left ventricular assist device implantation in patients with significant aortic insufficiency. We conducted a follow-up study to evaluate the efficacy and durability of this procedure. The study included patients who had undergone continuous flow left ventricular assist device implantation. The patients were divided into 2 groups, those who did not require any aortic procedure because the valve was competent and those who underwent central aortic valve closure for mild or greater aortic regurgitation. The clinical endpoints were mortality, progression or recurrence of aortic insufficiency, and reoperation for aortic valve pathologic features. Aortic insufficiency was measured qualitatively from mild to severe on a scale of 0 to 5. A total of 123 patients received continuous flow left ventricular assist devices from February 2007 to August 2011. Of those, 18 (15%) underwent central aortic valve closure at left ventricular assist device implantation because of significant aortic insufficiency (1.8 ± 1.4) and 105 who did not (competent aortic valve, 0.15 ± 0.43; P assist device-supported patients, with follow-up extending into 2 years. Although aortic insufficiency progressed over time in those with minimal native valve regurgitation initially, no such progression was noted in those with central aortic valve closure. Additional investigation is needed to evaluate whether prophylactic central aortic valve closure should be performed at left ventricular assist device implantation to avoid problematic aortic regurgitation developing over time, in particular in patients undergoing left ventricular assist device implantation for life-long (destination therapy) support. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights

The Feasibility of Using the BrightHearts Biofeedback-Assisted Relaxation Application for the Management of Pediatric Procedural Pain: A Pilot Study.

Science.gov (United States)

Burton, Karen L O; Morrow, Angela M; Beswick, Brooke V; Khut, George P

2018-04-17

The objective of this pilot study was to assess the acceptability and feasibility of using BrightHearts, a biofeedback-assisted relaxation application (app), in children undergoing painful procedures. Thirty children 7 to 18 years of age undergoing a medical procedure (peripheral blood collection, botulinum toxin injection, or intravenous cannula insertion) participated. Participants used BrightHearts, a heart rate-controlled biofeedback-assisted relaxation training app delivered via an iPad with heart rate measured through a pulse oximeter worn on the ear or thumb. Feasibility was assessed through observations and patient, parent/carer, and healthcare professional feedback. Patient, parent/carer, and healthcare professional satisfaction with BrightHearts was rated using investigator-developed surveys. Eighty-three percent of child participants reported that they found BrightHearts helpful during the procedure and that they would use BrightHearts again. All parents and 96% of healthcare professionals indicated they would use BrightHearts again. Sixty-four percent of healthcare providers perceived that BrightHearts assisted with the ease of performing the procedure. Qualitative analyses found 2 themes: (1) BrightHearts calms through providing distraction and biofeedback and (2) the impact of BrightHearts on the procedure. This pilot study demonstrates the feasibility of using biofeedback-assisted relaxation delivered via the BrightHearts app in children undergoing peripheral blood collection and cannulation. Future studies are required to evaluate BrightHearts' efficacy in reducing pain and anxiety during painful procedures and distinguish the effects of a biofeedback-mediated app from distraction. © 2018 World Institute of Pain.

Total Artificial Heart Implantation Blood Pressure Management as Resolving Treatment for Massive Hemolysis following Total Artificial Heart Implantation.

Science.gov (United States)

Ghodsizad, Ali; Koerner, Michael M; El-Banayosy, A; Zeriouh, Mohamed; Ruhparwar, Arjang; Loebe, Matthias

2016-10-21

The SynCardia Total Artificial Heart (TAH) has been used for patients with biventricular failure, who cannot be managed with implantation of a left ventricular (LV) assist device. Following TAH implantation, our patient developed severe hemolysis, which could only be managed successfully by aggressive blood pressure control [Ohashi 2003; Nakata 1998].

Energy transmission and power sources for mechanical circulatory support devices to achieve total implantability.

Science.gov (United States)

Wang, Jake X; Smith, Joshua R; Bonde, Pramod

2014-04-01

Left ventricular assist device therapy has radically improved congestive heart failure survival with smaller rotary pumps. The driveline used to power today's left ventricular assist devices, however, continues to be a source of infection, traumatic damage, and rehospitalization. Previous attempts to wirelessly power left ventricular assist devices using transcutaneous energy transfer systems have been limited by restrictions on separation distance and alignment between the transmit and receive coils. Resonant electrical energy transfer allows power delivery at larger distances without compromising safety and efficiency. This review covers the efforts to wirelessly power mechanical circulatory assist devices and the progress made in enhancing their energy sources. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Development of Hand Grip Assistive Device Control System for Old People through Electromyography (EMG) Signal Acquisitions

OpenAIRE

Khamis Herman; Mohamaddan Shahrol; Komeda Takashi; Alias Aidil Azli; Tanjong Shirley Jonathan; Julai Norhuzaimin; Hashim Nurul ‘Izzati

2017-01-01

The hand grip assistive device is a glove to assist old people who suffer from hand weakness in their daily life activities. The device earlier control system only use simple on and off switch. This required old people to use both hand to activate the device. The new control system of the hand grip assistive device was developed to allow single hand operation for old people. New control system take advantages of electromyography (EMG) and flex sensor which was implemented to the device. It wa...

Portable electrocardiogram device using Android smartphone.

Science.gov (United States)

Brucal, S G E; Clamor, G K D; Pasiliao, L A O; Soriano, J P F; Varilla, L P M

2016-08-01

Portable electrocardiogram (ECG) capturing device can be interfaced to a smart phone installed with an android-based application (app). This app processes and analyses the data sent by the device to provide an interpretation of the patient/user's heart current condition (e.g.: beats per minute, heart signal waveform, R-R interval). The ECG recorded by the app is stored in the smart phone's Secure Digital (SD) card and cloud storage which can be accessed remotely by a physician to aid in providing medical diagnosis. The project aims to help patients living at a far distance from hospitals and experience difficulty in consulting their physician for regular check-ups, and assist doctors in regularly monitoring their patient's heart condition. The hardware data acquisition device and software application were subjected to trials in a clinic with volunteer-patients to measure the ECG and heart rate, data saving speed on the SD card, success rate of the saved data and uploaded file. Different ECG tests using the project prototype were done for 12 patients/users and yielded a reading difference of 7.61% in an R-R interval reading and 5.35% in heart rate reading as compared with the cardiologist's conventional 12-electrode ECG machine. Using the developed ECG device, it took less than 5 seconds to save ECG reading using SD card and approximately 2 minutes to upload via cloud.

A Physical Heart Failure Simulation System Utilizing the Total Artificial Heart and Modified Donovan Mock Circulation.

Science.gov (United States)

Crosby, Jessica R; DeCook, Katrina J; Tran, Phat L; Betterton, Edward; Smith, Richard G; Larson, Douglas F; Khalpey, Zain I; Burkhoff, Daniel; Slepian, Marvin J

2017-07-01

With the growth and diversity of mechanical circulatory support (MCS) systems entering clinical use, a need exists for a robust mock circulation system capable of reliably emulating and reproducing physiologic as well as pathophysiologic states for use in MCS training and inter-device comparison. We report on the development of such a platform utilizing the SynCardia Total Artificial Heart and a modified Donovan Mock Circulation System, capable of being driven at normal and reduced output. With this platform, clinically relevant heart failure hemodynamics could be reliably reproduced as evidenced by elevated left atrial pressure (+112%), reduced aortic flow (-12.6%), blunted Starling-like behavior, and increased afterload sensitivity when compared with normal function. Similarly, pressure-volume relationships demonstrated enhanced sensitivity to afterload and decreased Starling-like behavior in the heart failure model. Lastly, the platform was configured to allow the easy addition of a left ventricular assist device (HeartMate II at 9600 RPM), which upon insertion resulted in improvement of hemodynamics. The present configuration has the potential to serve as a viable system for training and research, aimed at fostering safe and effective MCS device use. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Design and Development of a Miniaturized Percutaneously Deployable Wireless Left Ventricular Assist Device: Early Prototypes and Feasibility Testing.

Science.gov (United States)

Letzen, Brian; Park, Jiheum; Tuzun, Zeynep; Bonde, Pramod

The current left ventricular assist devices (LVADs) are limited by a highly invasive implantation procedure in a severely unstable group of advanced heart failure patients. Additionally, the current transcutaneous power drive line acts as a nidus for infection resulting in significant morbidity and mortality. In an effort to decrease this invasiveness and eliminate drive line complications, we have conceived a wireless miniaturized percutaneous LVAD, capable of being delivered endovascularly with a tether-free operation. The system obviates the need for a transcutaneous fluid purge line required in existing temporary devices by utilizing an incorporated magnetically coupled impeller for a complete seal. The objective of this article was to demonstrate early development and proof-of-concept feasibility testing to serve as the groundwork for future formalized device development. Five early prototypes were designed and constructed to iteratively minimize the pump size and improve fluid dynamic performance. Various magnetic coupling configurations were tested. Using SolidWorks and ANSYS software for modeling and simulation, several geometric parameters were varied. HQ curves were constructed from preliminary in vitro testing to characterize the pump performance. Bench top tests showed no-slip magnetic coupling of the impeller to the driveshaft up to the current limit of the motor. The pump power requirements were tested in vitro and were within the appropriate range for powering via a wireless energy transfer system. Our results demonstrate the proof-of-concept feasibility of a novel endovascular cardiac assist device with the potential to eventually offer patients an untethered, minimally invasive support.

Ventricular fibrillation in an ambulatory patient supported by a left ventricular assist device: highlighting the ICD controversy.

Science.gov (United States)

Boilson, Barry A; Durham, Lucian A; Park, Soon J

2012-01-01

Left ventricular assist devices (LVADs) provide an effective means of managing advanced pump failure as a means of bridging to cardiac transplantation or as permanent therapy. Although ventricular arrhythmias remain common post-LVAD implantation, such therapy may allow malignant arrhythmias to be tolerated hemodynamically. This report describes the clinical findings in a patient who had likely been in a ventricular tachyarrhythmia for several days and presented in ventricular fibrillation, ambulatory, and mentating normally. This report, with previous similar reports, is additive to the body of evidence that LVADs alter the physiologic impact of ventricular arrhythmias in advanced heart failure and highlights the need for thoughtful programming of implantable cardioverter defibrillator therapies in these patients.

Percutaneous Implantation of A Parachute Device For Treatment of Ischemic Heart Failure

Energy Technology Data Exchange (ETDEWEB)

Cilingiroglu, Mehmet, E-mail: mcilingiroglu@yahoo.com; Rollefson, William A.; Mego, David

2013-07-15

Congestive heart failure (CHF) secondary to ischemic cardiomyopathy is associated with significant morbidity and mortality despite currently available medical therapy. The Parachute{sup TM} device is a novel left ventricular partitioning device that is delivered percutaneously in the left ventricle (LV) in patients with anteroapical regional wall motion abnormalities, dilated LV and systolic dysfunction after anterior myocardial infarction with favorable clinical and LV hemodynamic improvements post-implantation. Here, we do review the current literature and present a case of the Parachute device implantation.

Percutaneous Implantation of A Parachute Device For Treatment of Ischemic Heart Failure

International Nuclear Information System (INIS)

Cilingiroglu, Mehmet; Rollefson, William A.; Mego, David

2013-01-01

Congestive heart failure (CHF) secondary to ischemic cardiomyopathy is associated with significant morbidity and mortality despite currently available medical therapy. The Parachute TM device is a novel left ventricular partitioning device that is delivered percutaneously in the left ventricle (LV) in patients with anteroapical regional wall motion abnormalities, dilated LV and systolic dysfunction after anterior myocardial infarction with favorable clinical and LV hemodynamic improvements post-implantation. Here, we do review the current literature and present a case of the Parachute device implantation

Network-Assisted Device-to-Device (D2D) Direct Proximity Discovery with Underlay Communication

DEFF Research Database (Denmark)

Pratas, Nuno; Popovski, Petar

2015-01-01

) direct communication between proximate devices. While (ii) is treated extensively in the recent literature, (i) has received relatively little attention. In this paper we analyze a network-assisted underlay proximity discovery protocol, where a cellular device can take the role of: announcer (which......Device-to-Device communications are expected to play an important role in current and future cellular generations, by increasing the spatial reuse of spectrum resources and enabling lower latency communication links. This paradigm has two fundamental building blocks: (i) proximity discovery and (ii......, we consider the case where the announcers underlay their messages in the downlink transmissions that are directed towards the monitoring devices. We propose a power control scheme applied to the downlink transmission, which copes with the underlay transmission via additional power expenditure, while...

Mechanical Circulatory Support for Advanced Heart Failure: Are We about to Witness a New "Gold Standard"?

Science.gov (United States)

Capoccia, Massimo

2016-12-12

The impact of left ventricular assist devices (LVADs) for the treatment of advanced heart failure has played a significant role as a bridge to transplant and more recently as a long-term solution for non-eligible candidates. Continuous flow left ventricular assist devices (CF-LVADs), based on axial and centrifugal design, are currently the most popular devices in view of their smaller size, increased reliability and higher durability compared to pulsatile flow left ventricular assist devices (PF-LVADs). The trend towards their use is increasing. Therefore, it has become mandatory to understand the physics and the mathematics behind their mode of operation for appropriate device selection and simulation set up. For this purpose, this review covers some of these aspects. Although very successful and technologically advanced, they have been associated with complications such as pump thrombosis, haemolysis, aortic regurgitation, gastro-intestinal bleeding and arterio-venous malformations. There is perception that the reduced arterial pulsatility may be responsible for these complications. A flow modulation control approach is currently being investigated in order to generate pulsatility in rotary blood pumps. Thrombus formation remains the most feared complication that can affect clinical outcome. The development of a preoperative strategy aimed at the reduction of complications and patient-device suitability may be appropriate. Patient-specific modelling based on 3D reconstruction from CT-scan combined with computational fluid dynamic studies is an attractive solution in order to identify potential areas of stagnation or challenging anatomy that could be addressed to achieve the desired outcome. The HeartMate II (axial) and the HeartWare HVAD (centrifugal) rotary blood pumps have been now used worldwide with proven outcome. The HeartMate III (centrifugal) is now emerging as the new promising device with encouraging preliminary results. There are now enough pumps on

The HeartShield device reduces the risk for right ventricular damage in patients with deep sternal wound infection.

Science.gov (United States)

Ingemansson, Richard; Malmsjö, Malin; Lindstedt, Sandra

2014-01-01

Right ventricular rupture, resulting in serious bleeding, is a life-threatening complication associated with negative-pressure wound therapy (NPWT) in cardiac surgery. The use of a rigid barrier between the heart and the sharp sternal edges has been successfully tested on pigs. In the present article, we demonstrate increased safety in NPWT through the use of the HeartShield device. Six patients were treated with a specially designed device in combination with NPWT. The device consists of a horizontally placed disk covered in foam. The back of the T-shaped device sticks up between the sternal edges and up above skin level. This part of the device is also covered in foam. Drainage is performed through two holes at the top of the device. The device and foam are changed every second to third day, and -120 mm Hg of continuous therapy is used. Six patients were treated with traditional NPWT, serving as control group. No signs of calluslike formation were seen on the right ventricle in the group treated with the HeartShield device. In the conventional NPWT control group, all six patients had calluslike formation (>1 × 2 cm2) on the anterior part of the right ventricle. All patients in the HeartShield group had grade 1 epicardial petechial bleeding (the right ventricle. In the control group, one patient had grade 1 (2.0 cm2) epicardial petechial bleeding on the right ventricle. No major bleeding or mortality was observed in either group during the course of the study. The use of the HeartShield device significantly minimizes the contact between the right ventricle and the sternal edges, thereby decreasing the risk for life-threatening complications due to bleeding.

Vocational Reintegration of Handicapped Workers with Assistive Devices

Science.gov (United States)

Cooper, N. E.

1977-01-01

Two approaches to vocational reintegration of handicapped workers are described: (1) adapting the disabled to the working environment through treatment, therapy, counseling, selective placement, and prostheses, and (2) adapting the working environment to particular handicaps, with the assistive device fitted to the machine or tool rather than to…

Smart Device for the Determination of Heart Rate Variability in Real Time

Directory of Open Access Journals (Sweden)

David Naranjo-Hernández

2017-01-01

Full Text Available This work presents a first approach to the design, development, and implementation of a smart device for the real-time measurement and detection of alterations in heart rate variability (HRV. The smart device follows a modular design scheme, which consists of an electrocardiogram (ECG signal acquisition module, a processing module and a wireless communications module. From five-minute ECG signals, the processing module algorithms perform a spectral estimation of the HRV. The experimental results demonstrate the viability of the smart device and the proposed processing algorithms.

Our experience with implantation of VentrAssist left ventricular assist device

Directory of Open Access Journals (Sweden)

Hiriyur Shivalingappa Jayanthkumar

2013-01-01

Full Text Available Perioperative anaesthetic management of the VentrAssist TM left ventricular assist device (LVAD is a challenge for anaesthesiologists because patients presenting for this operation have long-standing cardiac failure and often have associated hepatic and renal impairment, which may significantly alter the pharmacokinetics of administered drugs and render the patients coagulopathic. The VentrAssist is implanted by midline sternotomy. A brief period of cardiopulmonary bypass (CPB for apical cannulation of left ventricle is needed. The centrifugal pump, which produces non-pulsatile, continuous flow, is positioned in the left sub-diaphragmatic pocket. This LVAD is preload dependent and afterload sensitive. Transoesophageal echocardiography is an essential tool to rule out contraindications and to ensure proper inflow cannula position, and following the implantation of LVAD, to ensure right ventricular (RV function. The anaesthesiologist should be prepared to manage cardiac decompensation and acute desaturation before initiation of CPB, as well as RV failure and severe coagulopathic bleeding after CPB. Three patients had undergone implantation of VentrAssist in our hospital. This pump provides flow of 5 l/min depending on preload, afterload and pump speed. All the patients were discharged after an average of 30 days. There was no perioperative mortality.

Mechanical Circulatory Support for Advanced Heart Failure: Are We about to Witness a New “Gold Standard”?

Directory of Open Access Journals (Sweden)

Massimo Capoccia

2016-12-01

Full Text Available The impact of left ventricular assist devices (LVADs for the treatment of advanced heart failure has played a significant role as a bridge to transplant and more recently as a long-term solution for non-eligible candidates. Continuous flow left ventricular assist devices (CF-LVADs, based on axial and centrifugal design, are currently the most popular devices in view of their smaller size, increased reliability and higher durability compared to pulsatile flow left ventricular assist devices (PF-LVADs. The trend towards their use is increasing. Therefore, it has become mandatory to understand the physics and the mathematics behind their mode of operation for appropriate device selection and simulation set up. For this purpose, this review covers some of these aspects. Although very successful and technologically advanced, they have been associated with complications such as pump thrombosis, haemolysis, aortic regurgitation, gastro-intestinal bleeding and arterio-venous malformations. There is perception that the reduced arterial pulsatility may be responsible for these complications. A flow modulation control approach is currently being investigated in order to generate pulsatility in rotary blood pumps. Thrombus formation remains the most feared complication that can affect clinical outcome. The development of a preoperative strategy aimed at the reduction of complications and patient-device suitability may be appropriate. Patient-specific modelling based on 3D reconstruction from CT-scan combined with computational fluid dynamic studies is an attractive solution in order to identify potential areas of stagnation or challenging anatomy that could be addressed to achieve the desired outcome. The HeartMate II (axial and the HeartWare HVAD (centrifugal rotary blood pumps have been now used worldwide with proven outcome. The HeartMate III (centrifugal is now emerging as the new promising device with encouraging preliminary results. There are now

VENTRICLE ASSIST DEVICE: PAST, PRESENT, AND FUTURE NONPULSATILE PUMPS

Directory of Open Access Journals (Sweden)

G. Р. Itkin

2009-01-01

Full Text Available The article briefly describes the history of the non-pulsating type blood pumps for ventricular assist circulation and heart-lung machine. Disclosed the main advantages of these pumps before pulsating type, especially for implantable systems development. However, disadvantages of these pumps and the directions of minimize or eliminate ones have shown. Specific examples of our implantable centrifugal and axial pump developments are presented. Declare the ways to further improve the pumps. 

Cardiac transplantation after bridged therapy with continuous flow left ventricular assist devices.

Science.gov (United States)

Deo, Salil V; Sung, Kiick; Daly, Richard C; Shah, Ishan K; Altarabsheh, Salah E; Stulak, John M; Joyce, Lyle D; Boilson, Barry A; Kushwaha, Sudhir S; Park, Soon J

2014-03-01

Cardiac transplantation is an effective surgical therapy for end-stage heart failure. Patients (pts) may need to be bridged with a continuous flow left ventricular assist device (CF-LVAD) while on the transplant list as logistic factors like organ availability are unknown. Cardiac transplantation post-LVAD can be a surgically challenging procedure and outcome in these pts is perceived to be poorer based on experience with earlier generation pulsatile flow pumps. Data from a single institution comparing these pts with those undergoing direct transplantation in the present era of continuous flow device therapy are limited. Evaluate results of cardiac transplantation in pts bridged with a CF-LVAD (BTx) and compare outcomes with pts undergoing direct transplantation (Tx) in a single institution. From June 2007 till January 2012, 106 pts underwent cardiac transplantation. Among these, 37 (35%) pts (51±11 years; 85% male) were bridged with a CF-LVAD (BTx), while 70 (65%) comprised the Tx group (53±12 years; 72% males). The median duration of LVAD support was 227 (153,327) days. During the period of LVAD support, 10/37 (27%) pts were upgraded to status 1A and all were successfully transplanted. Median hospital stay in the BTx (14 days) was slightly longer than the Tx group (12 days) but not statistically significant (p=0.21). In-hospital mortality in the BTx (5%) and Tx (1%) were comparable (p=0.25). Estimated late survival in the BTx cohort was 94±7, 90±10 and 83±16% at the end of one, two and three years, respectively which was comparable to 97±4%, 93±6% and 89±9% for the Tx group (p=0.50). Cardiac transplantation after LVAD implant can be performed with excellent results. Patients can be supported on the left ventricular assist device even for periods close to a year with good outcome after cardiac transplantation. Copyright © 2013 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand

Non-Invasive Mapping of Intraventricular Flow Patterns in Patients Treated with Left Ventricular Assist Devices

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Miramontes, Marissa; Rossini, Lorenzo; Braun, Oscar; Brambatti, Michela; Almeida, Shone; Mizeracki, Adam; Martinez-Legazpi, Pablo; Benito, Yolanda; Bermejo, Javier; Kahn, Andrew; Adler, Eric; Del Álamo, Juan C.

2017-11-01

In heart failure patients, left ventricular (LV) assist devices (LVADs) decrease mortality and improve quality of life. We hypothesize echo color Doppler velocimetry (echo-CDV), an echocardiographic flow mapping modality, can non-invasively characterize the effect of LVAD support, optimize the device, thereby decreasing the stoke rate present in these patients. We used echo-CDV to image LV flow at baseline LVAD speed and during a ramp test in LVAD patients (Heartmate II, N =10). We tracked diastolic vortices and mapped blood stasis and cumulative shear. Compared to dilated cardiomyopathy (DCM) patients without LVADs, the flow had a less prominent diastolic vortex ring, and transited directly from mitral valve to cannula. Residence time and shear were significantly lower compared to healthy controls and DCMs. Aortic regurgitation and a large LV vortex presence or a direct mitral jet towards the cannula affected blood stasis region location and size. Flow patterns, residence time and shear depended on LV geometry, valve function and LVAD speed in a patient specific manner. This new methodology could be used with standard echo, hemodynamics and clinical information to find the flow optimizing LAVD setting minimizing stasis for each patient.

Identification of non-HLA antibodies in ventricular assist device recipients

Directory of Open Access Journals (Sweden)

Sandy von Salisch

2013-11-01

Full Text Available Aims Recipients of ventricular assist devices (VADR have a higher incidence to develop antibodies (Abs against human leukocyte antigens (HLA. Non-HLA antibodies like major histocompatibility complex class I-related chain A (MICA and autoantibodies against angiotensin type 1 receptor (AT1R and endothelin receptor A (ETAR are also implicated in the pathogenesis of acute rejection and allograft vasculopathy. We monitored non-HLA- and HLA-Abs in VADR up to one year after implantation. Materials and methods Sera of 56 VADR (54.1±12.8 years old, 50 men were analyzed for Abs against HLA-, MICA-, AT1R- and ETAR several times over one year after implantation using ELISA and Luminex xMAP technology. Blood transfusions, gender and age were reviewed. Results Sera of 56 VADR (54.1±12.8 years old, 50 men were analyzed for Abs against HLA-, MICA-, AT1R- and ETAR several times over one year after implantation using ELISA and Luminex xMAP technology. Blood transfusions, gender and age were reviewed. Conclusion Beside HLA- and MICA-Abs, VADR showed high titres of Abs against AT1R or ETAR, which underlines the necessity for monitoring non-HLA antibodies in VADR prior heart transplantation.

Clinical manifestations and management of left ventricular assist device-associated infections.

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Nienaber, Juhsien Jodi C; Kusne, Shimon; Riaz, Talha; Walker, Randall C; Baddour, Larry M; Wright, Alan J; Park, Soon J; Vikram, Holenarasipur R; Keating, Michael R; Arabia, Francisco A; Lahr, Brian D; Sohail, M Rizwan

2013-11-01

Infection is a serious complication of left ventricular assist device (LVAD) therapy. Published data regarding LVAD-associated infections (LVADIs) are limited by single-center experiences and use of nonstandardized definitions. We retrospectively reviewed 247 patients who underwent continuous-flow LVAD implantation from January 2005 to December 2011 at Mayo Clinic campuses in Minnesota, Arizona, and Florida. LVADIs were defined using the International Society for Heart and Lung Transplantation criteria. We identified 101 episodes of LVADI in 78 patients (32%) from this cohort. Mean age (± standard deviation [SD]) was 57±15 years. The majority (94%) underwent Heartmate II implantation, with 62% LVADs placed as destination therapy. The most common type of LVADIs were driveline infections (47%), followed by bloodstream infections (24% VAD related, and 22% non-VAD related). The most common causative pathogens included gram-positive cocci (45%), predominantly staphylococci, and nosocomial gram-negative bacilli (27%). Almost half (42%) of the patients were managed by chronic suppressive antimicrobial therapy. While 14% of the patients had intraoperative debridement, only 3 underwent complete LVAD removal. The average duration (±SD) of LVAD support was 1.5±1.0 years. At year 2 of follow-up, the cumulative incidence of all-cause mortality was estimated to be 43%. Clinical manifestations of LVADI vary on the basis of the type of infection and the causative pathogen. Mortality remained high despite combined medical and surgical intervention and chronic suppressive antimicrobial therapy. Based on clinical experiences, a management algorithm for LVADI is proposed to assist in the decision-making process.

Monitoring mobility assistive device use in post-stroke patients

DEFF Research Database (Denmark)

Boissy, Patrice; Hester, Todd; Sherrill, Delsey

2007-01-01

Mobility assistive devices (MAD) such as canes can improve mobility and allow independence in the performance of mobility-related tasks. The use of MAD is often prescribed for stroke survivors. Despite their acknowledged qualities, MAD in real life conditions are typically underutilized, misused...

Outcomes and hospital admissions during long-term support with a HeartMate II

DEFF Research Database (Denmark)

Rossing, Kasper; Jung, Mette Holme; Sander, Kaare

2015-01-01

OBJECTIVES: Continuous-flow left ventricular assist devices like the HeartMate II (HMII) improves survival in severe heart failure but little is known about the incidence and causes of hospitalizations during long-term support which was evaluated in this study. DESIGN: Observational follow-up study...... comprising all patients who received a HMII at our institution either as bridge-to-transplantation (BTT) or destination therapy (DT). All patients were followed from HMII implantation to transplantation, device explantation, death, or May 2015. RESULTS: The HMII was implanted in 66(44 BTT, 22 DT) patients...

Magnet-assisted device-level alignment for the fabrication of membrane-sandwiched polydimethylsiloxane microfluidic devices

International Nuclear Information System (INIS)

Lu, J-C; Liao, W-H; Tung, Y-C

2012-01-01

Polydimethylsiloxane (PDMS) microfluidic device is one of the most essential techniques that advance microfluidics research in recent decades. PDMS is broadly exploited to construct microfluidic devices due to its unique and advantageous material properties. To realize more functionalities, PDMS microfluidic devices with multi-layer architectures, especially those with sandwiched membranes, have been developed for various applications. However, existing alignment methods for device fabrication are mainly based on manual observations, which are time consuming, inaccurate and inconsistent. This paper develops a magnet-assisted alignment method to enhance device-level alignment accuracy and precision without complicated fabrication processes. In the developed alignment method, magnets are embedded into PDMS layers at the corners of the device. The paired magnets are arranged in symmetric positions at each PDMS layer, and the magnetic attraction force automatically pulls the PDMS layers into the aligned position during assembly. This paper also applies the method to construct a practical microfluidic device, a tunable chaotic micromixer. The results demonstrate the successful operation of the device without failure, which suggests the accurate alignment and reliable bonding achieved by the method. Consequently, the fabrication method developed in this paper is promising to be exploited to construct various membrane-sandwiched PDMS microfluidic devices with more integrated functionalities to advance microfluidics research. (paper)

Management of severe ischemic cardiomyopathy: left ventricular assist device as destination therapy versus conventional bypass and mitral valve surgery.

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Maltais, Simon; Tchantchaleishvili, Vahtang; Schaff, Hartzell V; Daly, Richard C; Suri, Rakesh M; Dearani, Joseph A; Topilsky, Yan; Stulak, John M; Joyce, Lyle D; Park, Soon J

2014-04-01

Patients with severe ischemic cardiomyopathy (left ventricular ejection fraction assist device as destination therapy is reserved for patients who are too high risk for conventional surgery. We evaluated our outcomes with conventional surgery within this population and the comparative effectiveness of these 2 therapies. We identified patients who underwent conventional surgery or left ventricular assist device as destination therapy for severe ischemic cardiomyopathy (left ventricular ejection fraction assist device as destination therapy. We compared baseline patient characteristics and outcomes in terms of end-organ function and survival. A total of 88 patients were identified; 55 patients underwent conventional surgery (63%), and 33 patients (37%) received a left ventricular assist device as destination therapy. Patients who received left ventricular assist device as destination therapy had the increased prevalence of renal failure, inotrope dependency, and intra-aortic balloon support. Patients undergoing conventional surgery required longer ventilatory support, and patients receiving a left ventricular assist device required more reoperation for bleeding. Mortality rates were similar between the 2 groups at 30 days (7% in the conventional surgery group vs 3% in the left ventricular assist device as destination therapy group, P = .65) and at 1 year (22% in the conventional surgery group vs 15% in the left ventricular assist device as destination therapy group, P = .58). There was a trend toward improved survival in patients receiving a left ventricular assist device compared with the propensity-matched groups at 1 year (94% vs 71%, P = .171). The operative mortality and early survival after conventional surgery seem to be acceptable. For inoperable or prohibitive-risk patients, left ventricular assist device as destination therapy can be offered with similar outcomes. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby

Heart-pulse Biofeedback in Playful Exercise using a Wearable device and Modular Interactive Tiles

DEFF Research Database (Denmark)

Shimokakimoto, Tomoya; Lund, Henrik Hautop; Suzuki, Kenji

2014-01-01

interactive tiles. The system consists of a wearable device that measures heart-pulse via ear-mounted sensor, and modular interactive tiles which are used for physical rehabilitation exercise through playing a game. The wearable devise enables detection of heart pulse in real-time and therefore provides heart...... beat rate during playful activities, even if the heart pulse wave have motion artifacts. The tiles are designed to build flexible structures and to provide immediate feedback based on the users’ physical interaction with the tiles. We combine the two systems to provide users with heart pulse...... biofeedback in playful exercise. We show that using the developed system it is possible for the users to regulate the exercise intensity on their own with biofeedback, and also possible to analyze exercise activity using number of steps on the tiles and heart beat rate....

Intraoperative bronchoscopic visualization of left ventricular assist device thrombus.

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Yost, Gardner; Bhat, Geetha; Modi, Sejal; Pappas, Pat; Tatooles, Antone

2016-07-01

Despite advancements in left ventricular assist device (LVAD) design and clinical management, device thrombosis remains a pertinent complication. Limited imaging makes precise visualization of clot location and shape very challenging. We report the usage of videobronchoscopic exploration of explanted LVADs for direct visualization of clot in two patients. This technique is a rapid and inexpensive means of improving our understanding of LVAD clot formation and may be useful in surgical exploration of inflow and outflow tracts during LVAD exchange. © The Author(s) 2015.

Heart Rate Detection Using Microsoft Kinect: Validation and Comparison to Wearable Devices.

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Gambi, Ennio; Agostinelli, Angela; Belli, Alberto; Burattini, Laura; Cippitelli, Enea; Fioretti, Sandro; Pierleoni, Paola; Ricciuti, Manola; Sbrollini, Agnese; Spinsante, Susanna

2017-08-02

Contactless detection is one of the new frontiers of technological innovation in the field of healthcare, enabling unobtrusive measurements of biomedical parameters. Compared to conventional methods for Heart Rate (HR) detection that employ expensive and/or uncomfortable devices, such as the Electrocardiograph (ECG) or pulse oximeter, contactless HR detection offers fast and continuous monitoring of heart activities and provides support for clinical analysis without the need for the user to wear a device. This paper presents a validation study for a contactless HR estimation method exploiting RGB (Red, Green, Blue) data from a Microsoft Kinect v2 device. This method, based on Eulerian Video Magnification (EVM), Photoplethysmography (PPG) and Videoplethysmography (VPG), can achieve performance comparable to classical approaches exploiting wearable systems, under specific test conditions. The output given by a Holter, which represents the gold-standard device used in the test for ECG extraction, is considered as the ground-truth, while a comparison with a commercial smartwatch is also included. The validation process is conducted with two modalities that differ for the availability of a priori knowledge about the subjects' normal HR. The two test modalities provide different results. In particular, the HR estimation differs from the ground-truth by 2% when the knowledge about the subject's lifestyle and his/her HR is considered and by 3.4% if no information about the person is taken into account.

Minimally Invasive Procedures - Direct and Video-Assisted Forms in the Treatment of Heart Diseases

International Nuclear Information System (INIS)

Castro, Josué Viana Neto; Melo, Emanuel Carvalho; Silva, Juliana Fernandes; Rebouças, Leonardo Lemos; Corrêa, Larissa Chagas; Germano, Amanda de Queiroz; Machado, João José Aquino

2014-01-01

Minimally invasive cardiovascular procedures have been progressively used in heart surgery. To describe the techniques and immediate results of minimally invasive procedures in 5 years. Prospective and descriptive study in which 102 patients were submitted to minimally invasive procedures in direct and video-assisted forms. Clinical and surgical variables were evaluated as well as the in hospital follow-up of the patients. Fourteen patients were operated through the direct form and 88 through the video-assisted form. Between minimally invasive procedures in direct form, 13 had aortic valve disease. Between minimally invasive procedures in video-assisted forms, 43 had mitral valve disease, 41 atrial septal defect and four tumors. In relation to mitral valve disease, we replaced 26 and reconstructed 17 valves. Aortic clamp, extracorporeal and procedure times were, respectively, 91,6 ± 21,8, 112,7 ± 27,9 e 247,1 ± 20,3 minutes in minimally invasive procedures in direct form. Between minimally invasive procedures in video-assisted forms, 71,6 ± 29, 99,7 ± 32,6 e 226,1 ± 42,7 minutes. Considering intensive care and hospitalization times, these were 41,1 ± 14,7 hours and 4,6 ± 2 days in minimally invasive procedures in direct and 36,8 ± 16,3 hours and 4,3 ± 1,9 days in minimally invasive procedures in video-assisted forms procedures. Minimally invasive procedures were used in two forms - direct and video-assisted - with safety in the surgical treatment of video-assisted, atrial septal defect and tumors of the heart. These procedures seem to result in longer surgical variables. However, hospital recuperation was faster, independent of the access or pathology

Frailty and outcomes after implantation of left ventricular assist device as destination therapy.

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Dunlay, Shannon M; Park, Soon J; Joyce, Lyle D; Daly, Richard C; Stulak, John M; McNallan, Sheila M; Roger, Véronique L; Kushwaha, Sudhir S

2014-04-01

Frailty is recognized as a major prognostic indicator in heart failure. There has been interest in understanding whether pre-operative frailty is associated with worse outcomes after implantation of a left ventricular assist device (LVAD) as destination therapy. Patients undergoing LVAD implantation as destination therapy at the Mayo Clinic, Rochester, Minnesota, from February 2007 to June 2012, were included in this study. Frailty was assessed using the deficit index (31 impairments, disabilities and comorbidities) and defined as the proportion of deficits present. We divided patients based on tertiles of the deficit index (>0.32 = frail, 0.23 to 0.32 = intermediate frail, <0.23 = not frail). Cox proportional hazard regression models were used to examine the association between frailty and death. Patients were censored at death or last follow-up through October 2013. Among 99 patients (mean age 65 years, 18% female, 55% with ischemic heart failure), the deficit index ranged from 0.10 to 0.65 (mean 0.29). After a mean follow-up of 1.9 ± 1.6 years, 79% of the patients had been rehospitalized (range 0 to 17 hospitalizations, median 1 per person) and 45% had died. Compared with those who were not frail, patients who were intermediate frail (adjusted HR 1.70, 95% CI 0.71 to 4.31) and frail (HR 3.08, 95% CI 1.40 to 7.48) were at increased risk for death (p for trend = 0.004). The mean (SD) number of days alive out of hospital the first year after LVAD was 293 (107) for not frail, 266 (134) for intermediate frail and 250 (132) for frail patients. Frailty before destination LVAD implantation is associated with increased risk of death and may represent a significant patient selection consideration. Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Evaluation of a focussed protocol for hand-held echocardiography and computer-assisted auscultation in detecting latent rheumatic heart disease in scholars.

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Zühlke, Liesl J; Engel, Mark E; Nkepu, Simpiwe; Mayosi, Bongani M

2016-08-01

Introduction Echocardiography is the diagnostic test of choice for latent rheumatic heart disease. The utility of echocardiography for large-scale screening is limited by high cost, complex diagnostic protocols, and time to acquire multiple images. We evaluated the performance of a brief hand-held echocardiography protocol and computer-assisted auscultation in detecting latent rheumatic heart disease with or without pathological murmur. A total of 27 asymptomatic patients with latent rheumatic heart disease based on the World Heart Federation criteria and 66 healthy controls were examined by standard cardiac auscultation to detect pathological murmur. Hand-held echocardiography using a focussed protocol that utilises one view - that is, the parasternal long-axis view - and one measurement - that is, mitral regurgitant jet - and a computer-assisted auscultation utilising an automated decision tool were performed on all patients. The sensitivity and specificity of computer-assisted auscultation in latent rheumatic heart disease were 4% (95% CI 1.0-20.4%) and 93.7% (95% CI 84.5-98.3%), respectively. The sensitivity and specificity of the focussed hand-held echocardiography protocol for definite rheumatic heart disease were 92.3% (95% CI 63.9-99.8%) and 100%, respectively. The test reliability of hand-held echocardiography was 98.7% for definite and 94.7% for borderline disease, and the adjusted diagnostic odds ratios were 1041 and 263.9 for definite and borderline disease, respectively. Computer-assisted auscultation has extremely low sensitivity but high specificity for pathological murmur in latent rheumatic heart disease. Focussed hand-held echocardiography has fair sensitivity but high specificity and diagnostic utility for definite or borderline rheumatic heart disease in asymptomatic patients.

A new approach to heart valve tissue engineering

DEFF Research Database (Denmark)

Kaasi, Andreas; Cestari, Idágene A.; Stolf, Noedir A G.

2011-01-01

The 'biomimetic' approach to tissue engineering usually involves the use of a bioreactor mimicking physiological parameters whilst supplying nutrients to the developing tissue. Here we present a new heart valve bioreactor, having as its centrepiece a ventricular assist device (VAD), which exposes...... chamber. Subsequently, applied vacuum to the pneumatic chamber causes the blood chamber to fill. A mechanical heart valve was placed in the VAD's inflow position. The tissue engineered (TE) valve was placed in the outflow position. The VAD was coupled in series with a Windkessel compliance chamber...

From Shuttle Main Engine to the Human Heart: A Presentation to the Federal Lab Consortium for Technology Transfer

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Fogarty, Jennifer A.

2010-01-01

A NASA engineer received a heart transplant performed by Drs. DeBakey and Noon after suffering a serious heart attack. 6 months later that engineer returned to work at NASA determined to use space technology to help people with heart disease. A relationship between NASA and Drs. DeBakey and Noon was formed and the group worked to develop a low cost, low power implantable ventricular assist device (VAD). NASA patented the method to reduce pumping damage to red blood cells and the design of a continuous flow heart pump (#5,678,306 and #5,947,892). The technology and methodology were licensed exclusively to MicroMed Technology, Inc.. In late 1998 MicroMed received international quality and electronic certifications and began clinical trials in Europe. Ventricular assist devices were developed to bridge the gap between heart failure and transplant. Early devices were cumbersome, damaged red blood cells, and increased the risk of developing dangerous blood clots. Application emerged from NASA turbopump technology and computational fluid dynamics analysis capabilities. To develop the high performance required of the Space Shuttle main engines, NASA pushed the state of the art in the technology of turbopump design. NASA supercomputers and computational fluid dynamics software developed for use in the modeling analysis of fuel and oxidizer flow through rocket engines was used in the miniaturization and optimization of a very small heart pump. Approximately 5 million people worldwide suffer from chronic heart failure at a cost of 40 billion dollars In the US, more than 5000 people are on the transplant list and less than 3000 transplants are performed each year due to the lack of donors. The success of ventricular assist devices has led to an application as a therapeutic destination as well as a bridge to transplant. This success has been attributed to smaller size, improved efficiency, and reduced complications such as the formation of blood clots and infection.

Development of Hand Grip Assistive Device Control System for Old People through Electromyography (EMG Signal Acquisitions

Directory of Open Access Journals (Sweden)

Khamis Herman

2017-01-01

Full Text Available The hand grip assistive device is a glove to assist old people who suffer from hand weakness in their daily life activities. The device earlier control system only use simple on and off switch. This required old people to use both hand to activate the device. The new control system of the hand grip assistive device was developed to allow single hand operation for old people. New control system take advantages of electromyography (EMG and flex sensor which was implemented to the device. It was programmed into active and semi-active mode operation. EMG sensors were placed on the forearm to capture EMG signal of Flexor Digitorum Profundus muscle to activate the device. Flex sensor was used to indicate the finger position and placed on top of the finger. The signal from both sensors then used to control the device. The new control system allowed single hand operation and designed to prevent user from over depended on the device by activating it through moving their fingers.

Domestic and foreign trends in the prevalence of heart failure and the necessity of next-generation artificial hearts: a survey by the Working Group on Establishment of Assessment Guidelines for Next-Generation Artificial Heart Systems.

Science.gov (United States)

Tatsumi, Eisuke; Nakatani, Takeshi; Imachi, Kou; Umezu, Mitsuo; Kyo, Shun-Ei; Sase, Kazuhiro; Takatani, Setsuo; Matsuda, Hikaru

2007-01-01

A series of guidelines for development and assessment of next-generation medical devices has been drafted under an interagency collaborative project by the Ministry of Health, Labor and Welfare and the Ministry of Economy, Trade and Industry. The working group for assessment guidelines of next-generation artificial hearts reviewed the trend in the prevalence of heart failure and examined the potential usefulness of such devices in Japan and in other countries as a fundamental part of the process of establishing appropriate guidelines. At present, more than 23 million people suffer from heart failure in developed countries, including Japan. Although Japan currently has the lowest mortality from heart failure among those countries, the number of patients is gradually increasing as our lifestyle becomes more Westernized; the associated medical expenses are rapidly growing. The number of heart transplantations, however, is limited due to the overwhelming shortage of donor hearts, not only in Japan but worldwide. Meanwhile, clinical studies and surveys have revealed that the major causes of death in patients undergoing long-term use of ventricular assist devices (VADs) were infection, thrombosis, and mechanical failure, all of which are typical of VADs. It is therefore of urgent and universal necessity to develop next-generation artificial hearts that have excellent durability to provide at least 2 years of event-free operation with a superior quality of life and that can be used for destination therapy to save patients with irreversible heart failure. It is also very important to ensure that an environment that facilitates the development, testing, and approval evaluation processes of next-generation artificial hearts be established as soon as possible.

The Effect of Preoperative Cognitive Behavior and Exercise Therapy for a Patient With an Implanted Left Ventricular Assist Device in Korea.

Science.gov (United States)

Seo, Yong Gon; Park, Won Hah; Jeon, Eun Seok; Sung, Ji Dong; Jang, Mi Ja

2017-10-01

Left ventricular assist devices (LVADs) are used in patients with progressive heart failure symptoms to provide circulatory support. Patients with LVADs are referred to inpatient cardiac rehabilitation to prevent postoperative complications and improve aerobic capacity and quality of life. Preoperative exercise therapy for cardiac patients is an emerging treatment modality, and several studies have reported that it improves postoperative outcomes, such as length of hospital stay and postoperative complications. This case report describes the benefits of preoperative cognitive behavioral and exercise therapy in a Korean patient undergoing LVAD implantation. V. Copyright © 2017 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Use of Ventricular Assist Device in Univentricular Physiology: The Role of Lumped Parameter Models.

Science.gov (United States)

Di Molfetta, Arianna; Ferrari, Gianfranco; Filippelli, Sergio; Fresiello, Libera; Iacobelli, Roberta; Gagliardi, Maria G; Amodeo, Antonio

2016-05-01

Failing single-ventricle (SV) patients might benefit from ventricular assist devices (VADs) as a bridge to heart transplantation. Considering the complex physiopathology of SV patients and the lack of established experience, the aim of this work was to realize and test a lumped parameter model of the cardiovascular system, able to simulate SV hemodynamics and VAD implantation effects. Data of 30 SV patients (10 Norwood, 10 Glenn, and 10 Fontan) were retrospectively collected and used to simulate patients' baseline. Then, the effects of VAD implantation were simulated. Additionally, both the effects of ventricular assistance and cavopulmonary assistance were simulated in different pathologic conditions on Fontan patients, including systolic dysfunction, diastolic dysfunction, and pulmonary vascular resistance increment. The model can reproduce patients' baseline well. Simulation results suggest that the implantation of VAD: (i) increases the cardiac output (CO) in all the three palliation conditions (Norwood 77.2%, Glenn 38.6%, and Fontan 17.2%); (ii) decreases the SV external work (SVEW) (Norwood 55%, Glenn 35.6%, and Fontan 41%); (iii) increases the mean pulmonary arterial pressure (Pap) (Norwood 39.7%, Glenn 12.1%, and Fontan 3%). In Fontan circulation, with systolic dysfunction, the left VAD (LVAD) increases CO (35%), while the right VAD (RVAD) determines a decrement of inferior vena cava pressure (Pvci) (39%) with 34% increment of CO. With diastolic dysfunction, the LVAD increases CO (42%) and the RVAD decreases the Pvci. With pulmonary vascular resistance increment, the RVAD allows the highest CO (50%) increment with the highest decrement of Pvci (53%). The single ventricular external work (SVEW) increases (decreases) increasing the VAD speed in cavopulmonary (ventricular) assistance. Numeric models could be helpful in this challenging and innovative field to support patients and VAD selection to optimize the clinical outcome and personalize the therapy

Role of ventricular assist therapy for patients with heart failure and restrictive physiology: Improving outcomes for a lethal disease.

Science.gov (United States)

Grupper, Avishay; Park, Soon J; Pereira, Naveen L; Schettle, Sarah D; Gerber, Yariv; Topilsky, Yan; Edwards, Brooks S; Daly, Richard C; Stulak, John M; Joyce, Lyle D; Kushwaha, Sudhir S

2015-08-01

Restrictive cardiomyopathy (RCM) patients have poor prognosis due to progressive heart failure characterized by impaired ventricular filling of either or both ventricles. The goal of this study was to evaluate the outcome of end-stage RCM patients after left ventricular assist device (LVAD) implantation and to determine factors that may be associated with improved survival. This investigation is a retrospective study of prospectively collected data that include 28 consecutive patients with end-stage RCM who received continuous-flow LVADs at the Mayo Clinic, Rochester, Minnesota. Outcome was assessed by survival with LVAD support until heart transplantation or all-cause mortality. The mean follow-up time post-LVAD implantation was 448 ± 425 days. The mean hospitalization time was 29 ± 19 days and was complicated mainly by post-operative right ventricular (RV) failure requiring short-term medical support. The short-term in-hospital mortality was 14%. Ten patients underwent heart transplantation with 100% survival post-transplant during the follow-up period. One-year survival for patients with LVADs without transplantation was 64%, and was not significantly different between amyloidosis and non-amyloidosis patients. Larger left ventricle (LV) end-diastolic and end-systolic dimensions were significantly associated with improved survival rates (RR = 0.94 and 0.95, p < 0.05, respectively), and left ventricular end-diastolic diameter (LVEDD) ≤46 mm was associated with increased mortality post-LVAD implantation. LVAD is a feasible, life-saving therapy for end-stage heart failure related to RCM, especially as a bridge to transplant and in patients with larger LV dimensions. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Device therapy in heart failure with reduced ejection fraction-cardiac resynchronization therapy and more.

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Duncker, D; Veltmann, C

2018-05-09

In patients with heart failure with reduced ejection fraction (HFrEF), optimal medical treatment includes beta-blockers, ACE inhibitors/angiotensinreceptor-neprilysin inhibitors (ARNI), mineralocorticoid receptor antagonists, and ivabradine when indicated. In device therapy of HFrEF, implantable cardioverter-defibrillators and cardiac resynchronization therapy (CRT) have been established for many years. CRT is the therapy of choice (class I indication) in symptomatic patients with HFrEF and a broad QRS complex with a left bundle branch block (LBBB) morphology. However, the vast majority of heart failure patients show a narrow QRS complex or a non-LBBB morphology. These patients are not candidates for CRT and alternative electrical therapies such as baroreflex activation therapy (BAT) and cardiac contractility modulation (CCM) may be considered. BAT modulates vegetative dysregulation in heart failure. CCM improves contractility, functional capacity, and symptoms. Although a broad data set is available for BAT and CCM, mortality data are still lacking for both methods. This article provides an overview of the device-based therapeutic options for patients with HFrEF.

Pulmonary Hypertension After Heart Transplantation in Patients Bridged with the Total Artificial Heart.

Science.gov (United States)

Shah, Rachit; Patel, Dhavalkumar B; Mankad, Anit K; Rennyson, Stephen L; Tang, Daniel G; Quader, Mohammed A; Smallfield, Melissa C; Kasirajan, Vigneshwar; Shah, Keyur B

2016-01-01

Pulmonary hypertension (PH) among heart transplant recipients is associated with an increased risk of mortality. Pulmonary hemodynamics improves after left ventricular assist device (LVAD) implantation; however, the impact of PH before total artificial heart (TAH) implantation on posttransplant hemodynamics and survival is unknown. This is a single center retrospective study aimed to evaluate the impact of TAH implantation on posttransplant hemodynamics and mortality in two groups stratified according to severity of PH: high (≥3 Woods units [WU]) and low (heart catheterization performed at baseline (before TAH) and posttransplant at 1 and 12 months. Patients in the high PVR group (n = 12) experienced improvement in PVR (baseline = 4.31 ± 0.7; 1-month = 1.69 ± 0.7, p heart transplantation (HT), but remained elevated. There was no significant difference in survival between the two groups at 12 months follow-up. Patients with high PVR who are bridged to transplant with TAH had improvement in PVR at 12 months after transplant, and the degree of PVR did not impact posttransplant survival.

Update for 2014 on clinical cardiology, geriatric cardiology, and heart failure and transplantation.

Science.gov (United States)

Barón-Esquivias, Gonzalo; Manito, Nicolás; López Díaz, Javier; Martín Santana, Antonio; García Pinilla, José Manuel; Gómez Doblas, Juan José; Gómez Bueno, Manuel; Barrios Alonso, Vivencio; Lambert, José Luis

2015-04-01

In the present article, we review publications from the previous year in the following 3 areas: clinical cardiology, geriatric cardiology, and heart failure and transplantation. Among the new developments in clinical cardiology are several contributions from Spanish groups on tricuspid and aortic regurgitation, developments in atrial fibrillation, syncope, and the clinical characteristics of heart disease, as well as various studies on familial heart disease and chronic ischemic heart disease. In geriatric cardiology, the most relevant studies published in 2014 involve heart failure, degenerative aortic stenosis, and data on atrial fibrillation in the geriatric population. In heart failure and transplantation, the most noteworthy developments concern the importance of multidisciplinary units and patients with preserved systolic function. Other notable publications were those related to iron deficiency, new drugs, and new devices and biomarkers. Finally, we review studies on acute heart failure and transplantation, such as inotropic drugs and ventricular assist devices. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

Science.gov (United States)

Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

2016-04-01

The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662

Stroke rehabilitation: assistive technology devices and environmental modifications following primary rehabilitation in hospital--a therapeutic perspective

DEFF Research Database (Denmark)

Sørensen, Hanne Vinkel; Lendal, Susie; Schultz-Larsen, Kirsten

2003-01-01

The aim of this article is to describe the need for assistive devices and environmental modifications among long-living stroke survivors and to investigate if the need is continued and growing over time. The study sample of 155 consecutive stroke patients with stroke-related impairment, discharged...... home from three hospitals in Copenhagen from 1996 through 1998, constituted 20% of the total population of stroke survivors in this area. The results showed that 75% of these patients were provided with assistive devices and/or environmental modifications at discharge. Six months after discharge...... be required in order to target stroke survivors' changing needs for assistive devices and environmental modifications....

Past and Present of Total Artificial Heart Therapy: A Success Story

Science.gov (United States)

Samak, Mostafa; Fatullayev, Javid; Sabashnikov, Anton; Zeriouh, Mohamed; Rahmanian, Parwis B.; Choi, Yeong-Hoon; Wippermann, Jens; Wahlers, Thorsten; Schmack, Bastian; Ruhparwar, Arjang; Dohmen, Pascal M.; Karck, Matthias; Popov, Aron-Frederik; Simon, André R.; Weymann, Alexander

2015-01-01

The totally artificial heart (TAH) is among the most prominent medical innovations of the 21st century, especially due to the increasing population with end-stage heart failure. The progressive course of the disease, its resistance to conventional therapy, and the scarcity of hearts available for transplantation were the prime impetus for developing a TAH, especially when other options of mechanical circulatory assist devices are exhausted. In this review, we narrate the history of TAH, give an overview of its technology, and address the pros and cons of the currently available TAH models in light of published clinical experience. PMID:26343363

Past and Present of Total Artificial Heart Therapy: A Success Story.

Science.gov (United States)

Samak, Mostafa; Fatullayev, Javid; Sabashnikov, Anton; Zeriouh, Mohamed; Rahmanian, Parwis B; Choi, Yeong-Hoon; Wippermann, Jens; Wahlers, Thorsten; Schmack, Bastian; Ruhparwar, Arjang; Dohmen, Pascal M; Karck, Matthias; Popov, Aron-Frederik; Simon, André R; Weymann, Alexander

2015-09-07

The totally artificial heart (TAH) is among the most prominent medical innovations of the 21st century, especially due to the increasing population with end-stage heart failure. The progressive course of the disease, its resistance to conventional therapy, and the scarcity of hearts available for transplantation were the prime impetus for developing a TAH, especially when other options of mechanical circulatory assist devices are exhausted. In this review, we narrate the history of TAH, give an overview of its technology, and address the pros and cons of the currently available TAH models in light of published clinical experience.

Left ventricular assist device as bridge to recovery for anthracycline-induced terminal heart failure

DEFF Research Database (Denmark)

Appel, Jon M; Sander, Kåre; Hansen, Peter Bo

2012-01-01

Anthracycline treatments are hampered by dose-related cardiotoxicity, frequently leading to heart failure (HF) with a very poor prognosis. The authors report a case of a 19-year-old man developing HF after anthracycline treatment for Ewing sarcoma. Despite medical treatment, his condition...

The Impact of Obesity on Patients Bridged to Transplantation With Continuous-Flow Left Ventricular Assist Devices.

Science.gov (United States)

Clerkin, Kevin J; Naka, Yoshifumi; Mancini, Donna M; Colombo, Paolo C; Topkara, Veli K

2016-10-01

This study sought to determine if obese patients had worse post-left ventricular assist device (LVAD) implantation outcomes and if the implantation of an LVAD allowed for weight loss. Obesity is a risk factor for cardiovascular disease including heart failure. Obese heart failure patients have better outcomes than those with normal weight; however, obese patients have worse outcomes after heart transplantation. Patients were identified in the United Network for Organ Sharing (UNOS) database that underwent LVAD implantation as bridge to transplantation from May 2004 and April 2014, with follow-up through June 2014. Patients were grouped according to body mass index (BMI) based on the World Health Organization classification. Among 3,856 patients, the risk of death or delisting was not significantly different between BMI groups (p = 0.347). There was no increased risk of death (p = 0.234) or delisting (p = 0.918). The risk of complication requiring UNOS status upgrade was increased for those with class II obesity or greater (hazard ratio: 1.48; p = 0.004), driven by increased infection and thromboembolism. Obese patients had worse post-transplantation outcomes. Weight loss substantial enough to decrease BMI group was achieved by a small proportion of patients listed with class I obesity or greater (9.6% to 15.5%). Patients with obesity had similar freedom from death or delisting while on LVAD support. However, class II obese or greater patients had an increased risk of complications requiring UNOS status upgrade compared with those with normal BMI during LVAD support and decreased post-transplantation survival. Weight loss on device therapy was possible, but uncommon. Careful consideration is needed when a bridge to weight loss strategy is proposed. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Robot-assisted training for heart failure patients - a small pilot study.

Science.gov (United States)

Schoenrath, Felix; Markendorf, Susanne; Brauchlin, Andreas Emil; Frank, Michelle; Wilhelm, Markus Johannes; Saleh, Lanja; Riener, Robert; Schmied, Christian Marc; Falk, Volkmar

2015-12-01

The objective of this study was assess robot-assisted gait therapy with the Lokomat® system in heart failure patients. Patients (n = 5) with stable heart failure and a left ventricular ejection fraction of less than 45% completed a four-week aerobic training period with three trainings per week and an integrated dynamic resistance training of the lower limbs. Patients underwent testing of cardiac and inflammatory biomarkers. A cardiopulmonary exercise test, a quality of life score and an evaluation of the muscular strength by measuring the peak quadriceps force was performed. No adverse events occurred. The combined training resulted in an improvement in peak work rate (range: 6% to 36%) and peak quadriceps force (range: 3% to 80%) in all participants. Peak oxygen consumption (range: –3% to + 61%) increased in three, and oxygen pulse (range: –7% to + 44%) in four of five patients. The quality of life assessment indicated better well-being in all participants. NT-ProBNP (+233 to –733 ng/ml) and the inflammatory biomarkers (hsCRP and IL6) decreased in four of five patients (IL 6: +0.5 to –2 mg/l, hsCRP: +0.2 to –6.5 mg/l). Robot-assisted gait therapy with the Lokomat® System is feasible in heart failure patients and was safe in this trial. The combined aerobic and resistance training intervention with augmented feedback resulted in benefits in exercise capacity, muscle strength and quality of life, as well as an improvement of cardiac (NT-ProBNP) and inflammatory (IL6, hsCRP) biomarkers. Results can only be considered as preliminary and need further validation in larger studies. (ClinicalTrials.gov number, NCT 02146196)

Impact of interface charge on the electrostatics of field-plate assisted RESURF devices

NARCIS (Netherlands)

Boksteen, B.K.; Ferrara, A.; Heringa, A.; Steeneken, P.G.; Hueting, Raymond Josephus Engelbart

2014-01-01

A systematic study on the effects of arbitrary parasitic charge profiles, such as trapped or fixed charge, on the 2-D potential distribution in the drain extension of reverse-biased field-plate-assisted reduced surface field (RESURF) devices is presented. Using TCAD device simulations and analytical

Investigating perioperative heart migration during robot-assisted coronary artery bypass grafting interventions.

Science.gov (United States)

Linte, Cristian A; Cho, Daniel S; Wedlake, Chris; Moore, John; Chen, Elvis; Bainbridge, Daniel; Patel, Rajni; Peters, Terry; Kiaii, Bob B

2011-09-01

: For robot-assisted coronary artery bypass graft interventions, surgeons typically use a preoperative thoracic computed tomography scan of the patient to plan the procedure. However, the cardiac anatomy is prone to changes induced perioperatively in the effort to access the heart and surgical targets, which, in turn, may invalidate the initial plan. This article presents a method to estimate the perioperative heart migration, information which can be further exploited to refine the preoperative surgical plan. : Tracked transesophageal ultrasound images of four patients' hearts were acquired at each stage in the procedure: before lung deflation, after lung deflation, and after both lung deflation and CO2 thoracic insufflation. Anatomic features of interest-the mitral and aortic valves-were identified from each dataset, and their movement between the different procedure stages was recorded and used to estimate the global heart displacement. Moreover, the local morphology of the features of interest was investigated to provide insight on the extent of the deformation the heart has undergone during the workflow. : The study suggested that the heart does undergo substantial displacement-on the order of 10 to 15 mm in each direction (axial, coronal, and sagittal) after lung deflation and CO2 thoracic insufflation. However, no significant differences (P > 0.1) were observed in the morphologic characteristics of the features of interest across the multiple workflow stages, suggesting that local deformations occur at a much smaller scale compared with the global migration. : The quantification of the perioperatively induced changes is critical to track the displacement of the heart and surgical targets. The recorded migration patterns should not be ignored but rather be used to update the surgical plan to better suit the intraoperative environment.

Sensor-Based Assistive Devices for Visually-Impaired People: Current Status, Challenges, and Future Directions

Directory of Open Access Journals (Sweden)

Wafa Elmannai

2017-03-01

Full Text Available The World Health Organization (WHO reported that there are 285 million visuallyimpaired people worldwide. Among these individuals, there are 39 million who are totally blind. There have been several systems designed to support visually-impaired people and to improve the quality of their lives. Unfortunately, most of these systems are limited in their capabilities. In this paper, we present a comparative survey of the wearable and portable assistive devices for visuallyimpaired people in order to show the progress in assistive technology for this group of people. Thus, the contribution of this literature survey is to discuss in detail the most significant devices that are presented in the literature to assist this population and highlight the improvements, advantages, disadvantages, and accuracy. Our aim is to address and present most of the issues of these systems to pave the way for other researchers to design devices that ensure safety and independent mobility to visually-impaired people.

Sensor-Based Assistive Devices for Visually-Impaired People: Current Status, Challenges, and Future Directions

Science.gov (United States)

Elmannai, Wafa; Elleithy, Khaled

2017-01-01

The World Health Organization (WHO) reported that there are 285 million visually-impaired people worldwide. Among these individuals, there are 39 million who are totally blind. There have been several systems designed to support visually-impaired people and to improve the quality of their lives. Unfortunately, most of these systems are limited in their capabilities. In this paper, we present a comparative survey of the wearable and portable assistive devices for visually-impaired people in order to show the progress in assistive technology for this group of people. Thus, the contribution of this literature survey is to discuss in detail the most significant devices that are presented in the literature to assist this population and highlight the improvements, advantages, disadvantages, and accuracy. Our aim is to address and present most of the issues of these systems to pave the way for other researchers to design devices that ensure safety and independent mobility to visually-impaired people. PMID:28287451

Heart transplantation for adults with congenital heart disease: current status and future prospects.

Science.gov (United States)

Matsuda, Hikaru; Ichikawa, Hajime; Ueno, Takayoshi; Sawa, Yoshiki

2017-06-01

Increased survival rates after corrective or palliative surgery for complex congenital heart disease (CHD) in infancy and childhood are now being coupled with increased numbers of patients who survive to adulthood with various residual lesions or sequelae. These patients are likely to deteriorate in cardiac function or end-organ function, eventually requiring lifesaving treatment including heart transplantation. Although early and late outcomes of heart transplantation have been improving for adult survivors of CHD, outcomes and pretransplant management could still be improved. Survivors of Fontan procedures are a vulnerable cohort, particularly when single ventricle physiology fails, mostly with protein-losing enteropathy and hepatic dysfunction. Therefore, we reviewed single-institution and larger database analyses of adults who underwent heart transplantation for CHD, to enable risk stratification by identifying the indications and outcomes. As the results, despite relatively high early mortality, long-term results were encouraging after heart transplantation. However, further investigations are needed to improve the indication criteria for complex CHD, especially for failed Fontan. In addition, the current system of status criteria and donor heart allocation system in heart transplantation should be arranged as suitable for adults with complex CHD. Furthermore, there is a strong need to develop ventricular assist devices as a bridge to transplantation or destination therapy, especially where right-sided circulatory support is needed.

Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients.

Science.gov (United States)

Cowger, Jennifer A; Naka, Yoshifumi; Aaronson, Keith D; Horstmanshof, Douglas; Gulati, Sanjeev; Rinde-Hoffman, Debbie; Pinney, Sean; Adatya, Sirtaz; Farrar, David J; Jorde, Ulrich P

2018-01-01

The Multicenter Study of MAGLEV Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) clinical trial demonstrated improved 6-month event-free survival, but a detailed analysis of health-related quality of life (HR-QOL) and functional capacity (FC) was not presented. Further, the effect of early serious adverse events (SAEs) on these metrics and on the general ability to live well while supported with a left ventricular assist system (LVAS) warrants evaluation. FC (New York Heart Association [NYHA] and 6-minute walk test [6MWT]) and HR-QOL (European Quality of Life [EQ-5D-5L] and the Kansas City Cardiomyopathy [KCCQ]) assessments were obtained at baseline and 6 months after HeartMate 3 (HM3, n = 151; Abbott, Abbott Park, IL) or HeartMate II (HMII, n = 138; Abbott) implant as part of the MOMENTUM 3 clinical trial. Metrics were compared between devices and in those with and without events. The proportion of patients "living well on an LVAS" at 6 months, defined as alive with satisfactory FC (NYHA I/II or 6MWT > 300 meters) and HR-QOL (overall KCCQ > 50), was evaluated. Although the median (25th-75th percentile) patient KCCQ (change for HM3: +28 [10-46]; HMII: +29 [9-48]) and EQ-5D-5L (change for HM3: -1 [-5 to 0]; HMII: -2 [-6 to 0]) scores improved from baseline to 6 months (p 0.05). Likewise, there was an equivalent improvement in 6MWT distance at 6 months in HM3 (+94 [1-274] meters] and HMII (+188[43-340 meters]) from baseline. In patients with SAEs (n = 188), 6MWTs increased from baseline (p < 0.001), but gains for both devices were less than those without SAE (HM3: +74 [-9 to 183] meters with SAE vs +140 [35-329] meters without SAE; HMII: +177 [47-356] meters with SAE vs +192 [23-337] meters without SAE, both p < 0.003). SAEs did not affect the 6-month HR-QOL scores. The "living well" end point was achieved in 145 HM3 (63%) and 120 HMII (68%) patients (p = 0.44). Gains in HR-QOL and FC were similar early after HM3

Formation of a national network for rapid response to device and lead advisories: The Canadian Heart Rhythm Society Device Advisory Committee

Science.gov (United States)

Krahn, Andrew D; Simpson, Christopher S; Parkash, Ratika; Yee, Raymond; Champagne, Jean; Healey, Jeffrey S; Cameron, Doug; Thibault, Bernard; Mangat, Iqwal; Tung, Stanley; Sterns, Laurence; Birnie, David H; Exner, Derek V; Sivakumaran, Soori; Davies, Ted; Coutu, Benoit; Crystal, Eugene; Wolfe, Kevin; Verma, Atul; Stephenson, Elizabeth A; Sanatani, Shubhayan; Gow, Robert; Connors, Sean; Paredes, Felix Ayala; Turabian, Mike; Kus, Teresa; Essebag, Vidal; Gardner, Martin

2009-01-01

The Canadian Heart Rhythm Society (CHRS) Device Advisory Committee was commissioned to respond to advisories regarding cardiac rhythm device and lead performance on behalf of the CHRS. In the event of an advisory, the Chair uses an e-mail network to disseminate advisory information to Committee members broadly representative of the Canadian device community. A consensus recommendation is prepared by the Committee and made available to all Canadian centres on the CHRS Web site after approval by the CHRS executive. This collaborative approach using an e-mail network has proven very efficient in providing a rapid national response to device advisories. The network is an ideal tool to collect specific data on implanted device system performance and allows for prompt reporting of clinically relevant data to front-line clinicians and patients. PMID:19584969

Flow visualization of three-dimensionality inside the 12 cc Penn State pulsatile pediatric ventricular assist device.

Science.gov (United States)

Roszelle, Breigh N; Deutsch, Steven; Manning, Keefe B

2010-02-01

In order to aid the ongoing concern of limited organ availability for pediatric heart transplants, Penn State has continued development of a pulsatile Pediatric Ventricular Assist Device (PVAD). Initial studies of the PVAD observed an increase in thrombus formation due to differences in flow field physics when compared to adult sized devices, which included a higher degree of three-dimensionality. This unique flow field brings into question the use of 2D planar particle image velocimetry (PIV) as a flow visualization technique, however the small size and high curvature of the PVAD make other tools such as stereoscopic PIV impractical. In order to test the reliability of the 2D results, we perform a pseudo-3D PIV study using planes both parallel and normal to the diaphragm employing a mock circulatory loop containing a viscoelastic fluid that mimics 40% hematocrit blood. We find that while the third component of velocity is extremely helpful to a physical understanding of the flow, particularly of the diastolic jet and the development of a desired rotational pattern, the flow data taken parallel to the diaphragm is sufficient to describe the wall shear rates, a critical aspect to the study of thrombosis and design of such pumps.

The impact of mobility assistive technology devices on participation for individuals with disabilities.

Science.gov (United States)

Carver, Jordan; Ganus, Ashley; Ivey, Jon Mark; Plummer, Teresa; Eubank, Ann

2016-08-01

This study aims to address the gap in research and contribute to the body of knowledge on the perspectives assistive technology device users have toward their devices. Mixed methods were used to better understand the impact of mobility assistive technology devices (MATDs) on participation for individuals with disabilities. The Functional Mobility Assessment was administered in conjunction with two qualitative questions developed by the research team allowing participants to expound on the impact of their MATD experience. Participants were recruited online via the National Spinal Cord Injury Association website and in-person at Abilities Expo in Atlanta, Georgia, and the International Seating Symposium in Nashville, Tennessee. Results are consistent with findings from prior research regarding accessibility for individuals with disabilities. Corresponding findings were found in both the quantitative and qualitative data and are categorized into several major themes: environment (indoor and outdoor), surface heights, transportation, dependence, independence, quality of life and participation. Quantitative data from this study indicate that users of MATD are satisfied with the way in which their devices enable maneuvering indoors, while qualitative data suggest otherwise. Implications for healthcare practitioners are described and future recommendations are provided. Implications for Rehabilitation Healthcare professionals should advocate for proper mobility assistive technology devices (MATDs) for their patients in order to enable increased independence, safety and efficiency. Healthcare professionals must be cognizant of the impact of the environment and/or environmental barriers when prescribing MATD. Additional areas of interest for future research may include investigating the impact of MATD in association with date of onset of disability, according to diagnoses, or specific to length of time since acquiring the device.

14 CFR 382.121 - What mobility aids and other assistive devices may passengers with a disability bring into the...

Science.gov (United States)

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false What mobility aids and other assistive... Aids, and Other Assistive Devices § 382.121 What mobility aids and other assistive devices may... or collapsible wheelchairs; (2) Other mobility aids, such as canes (including those used by persons...

Impact of left ventricular assist device speed adjustment on exercise tolerance and markers of wall stress.

Science.gov (United States)

Hayward, Christopher S; Salamonsen, Robert; Keogh, Anne M; Woodard, John; Ayre, Peter; Prichard, Roslyn; Kotlyar, Eugene; Macdonald, Peter S; Jansz, Paul; Spratt, Phillip

2015-09-01

Left ventricular assist devices are crucial in rehabilitation of patients with end-stage heart failure. Whether cardiopulmonary function is enhanced with higher pump output is unknown. 10 patients (aged 39±16 years, mean±SD) underwent monitored adjustment of pump speed to determine minimum safe low speed and maximum safe high speed at rest. Patients were then randomized to these speed settings and underwent three 6-minute walk tests (6MWT) and symptom-limited cardiopulmonary stress tests (CPX) on separate days. Pump speed settings (low, normal and high) resulted in significantly different resting pump flows of 4.43±0.6, 5.03±0.94, and 5.72±1.2 l/min (Pexercise (Pexercise time (p=.27). Maximum workload achieved and peak oxygen consumption were significantly different comparing low to high pump speed settings only (Prelease was significantly reduced at higher pump speed with exercise (Prelease consistent with lower myocardial wall stress. This did not, however, improve exercise tolerance.

Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device.

Science.gov (United States)

Richardson, Travis D; Hale, Leslie; Arteaga, Christopher; Xu, Meng; Keebler, Mary; Schlendorf, Kelly; Danter, Matthew; Shah, Ashish; Lindenfeld, JoAnn; Ellis, Christopher R

2018-02-23

Ventricular arrhythmias are common in patients with left ventricular assist devices (LVADs) but are often hemodynamically tolerated. Optimal implantable cardioverter defibrillator (ICD) tachy-programming strategies in patients with LVAD have not been determined. We sought to determine if an ultra-conservative ICD programming strategy in patients with LVAD affects ICD shocks. Adult patients with an existing ICD undergoing continuous flow LVAD implantation were randomized to standard ICD programming by their treating physician or an ultra-conservative ICD programming strategy utilizing maximal allowable intervals to detection in the ventricular fibrillation and ventricular tachycardia zones with use of ATP. Patients with cardiac resynchronization therapy (CRT) devices were also randomized to CRT ON or OFF. Patients were followed a minimum of 6 months. The primary outcome was time to first ICD shock. Among the 83 patients studied, we found no statistically significant difference in time to first ICD shock or total ICD shocks between groups. In the ultra-conservative group 16% of patients experienced at least one shock compared with 21% in the control group ( P =0.66). There was no difference in mortality, arrhythmic hospitalization, or hospitalization for heart failure. In the 41 patients with CRT ICDs fewer shocks were observed with CRT-ON but this was not statistically significant: 10% of patients with CRT-ON (n=21) versus 38% with CRT-OFF (n=20) received shocks ( P =0.08). An ultra-conservative programming strategy did not reduce ICD shocks. Programming restrictions on ventricular tachycardia and ventricular fibrillation zone therapy should be reconsidered for the LVAD population. The role of CRT in patients with LVAD warrants further investigation. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01977703. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

NHLBI's program for VAD therapy for moderately advanced heart failure: the REVIVE-IT pilot trial.

Science.gov (United States)

Baldwin, J Timothy; Mann, Douglas L

2010-11-01

Ventricular assist devices (VADs) are used to bridge heart failure patients to transplantation, to allow their own hearts to recover, or as permanent ("destination") therapy. To date, the use of VADs has been limited to late-stage heart failure patients because of the associated device risks. In 2008, a National Heart, Lung, and Blood Institute (NHLBI) working group met to evaluate the treatment of heart failure using VADs and to advise the institute on how therapy for heart failure may be best advanced by clinical trials involving the devices. Recognizing the improvements in VAD technology and in patient care and selection over the past decade, the working group recommended that a trial be performed to assess the use of chronic VAD therapy in patients who are less ill than those currently eligible for destination therapy. The hypothesis proposed for the trial is that VAD therapy may improve both survival and quality of life in moderately advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility. Based on the group's recommendations, NHLBI issued an RFP in 2009 for the REVIVE-IT Pilot Trail, which will serve to test the hypothesis and inform the pivotal trial. Published by Elsevier Inc.

SdrF, a Staphylococcus epidermidis surface protein, contributes to the initiation of ventricular assist device driveline-related infections.

Directory of Open Access Journals (Sweden)

Carlos Arrecubieta

2009-05-01

Full Text Available Staphylococcus epidermidis remains the predominant pathogen in prosthetic-device infections. Ventricular assist devices, a recently developed form of therapy for end-stage congestive heart failure, have had considerable success. However, infections, most often caused by Staphylococcus epidermidis, have limited their long-term use. The transcutaneous driveline entry site acts as a potential portal of entry for bacteria, allowing development of either localized or systemic infections. A novel in vitro binding assay using explanted drivelines obtained from patients undergoing transplantation and a heterologous lactococcal system of surface protein expression were used to identify S. epidermidis surface components involved in the pathogenesis of driveline infections. Of the four components tested, SdrF, SdrG, PIA, and GehD, SdrF was identified as the primary ligand. SdrF adherence was mediated via its B domain attaching to host collagen deposited on the surface of the driveline. Antibodies directed against SdrF reduced adherence of S. epidermidis to the drivelines. SdrF was also found to adhere with high affinity to Dacron, the hydrophobic polymeric outer surface of drivelines. Solid phase binding assays showed that SdrF was also able to adhere to other hydrophobic artificial materials such as polystyrene. A murine model of infection was developed and used to test the role of SdrF during in vivo driveline infection. SdrF alone was able to mediate bacterial adherence to implanted drivelines. Anti-SdrF antibodies reduced S. epidermidis colonization of implanted drivelines. SdrF appears to play a key role in the initiation of ventricular assist device driveline infections caused by S. epidermidis. This pluripotential adherence capacity provides a potential pathway to infection with SdrF-positive commensal staphylococci first adhering to the external Dacron-coated driveline at the transcutaneous entry site, then spreading along the collagen

Reduced size liver transplantation from a donor supported by a Berlin Heart.

Science.gov (United States)

Misra, M V; Smithers, C J; Krawczuk, L E; Jenkins, R L; Linden, B C; Weldon, C B; Kim, H B

2009-11-01

Patients on cardiac assist devices are often considered to be high-risk solid organ donors. We report the first case of a reduced size liver transplant performed using the left lateral segment of a pediatric donor whose cardiac function was supported by a Berlin Heart. The recipient was a 22-day-old boy with neonatal hemochromatosis who developed fulminant liver failure shortly after birth. The transplant was complicated by mild delayed graft function, which required delayed biliary reconstruction and abdominal wall closure, as well as a bile leak. However, the graft function improved quickly over the first week and the patient was discharged home with normal liver function 8 weeks after transplant. The presence of a cardiac assist device should not be considered an absolute contraindication for abdominal organ donation. Normal organ procurement procedures may require alteration due to the unusual technical obstacles that are encountered when the donor has a cardiac assist device.

Intelligent speed adaptation as an assistive device for drivers with acquired brain injury

DEFF Research Database (Denmark)

Klarborg, Brith; Lahrmann, Harry Spaabæk; Agerholm, Niels

2012-01-01

Intelligent speed adaptation (ISA) was tested as an assistive device for drivers with an acquired brain injury (ABI). The study was part of the “Pay as You Speed” project (PAYS) and used the same equipment and technology as the main study (Lahrmann et al., in press-a, in press-b). Two drivers......, and in general they described driving with ISA as relaxed. ISA reduced the percentage of the total distance that was driven with a speed above the speed limit (PDA), but the subjects relapsed to their previous PDA level in Baseline 2. This suggests that ISA is more suited as a permanent assistive device (i...

Bioartificial liver assist devices in support of patients with liver failure.

Science.gov (United States)

Patzer II, John F; Lopez, Roberto C; Zhu, Yue; Wang, Zi-Fa; Mazariegos, George V; Fung, John J

2002-02-01

Bioartificial liver assist devices (BALs) offer an opportunity for critical care physicians and transplant surgeons to stabilize patients prior to orthotopic liver transplantation. Such devices may also act as a bridge to transplant, providing liver support to patients awaiting transplant, or as support for patients post living-related donor transplant. Four BAL devices that rely on hepatocytes cultured in hollow fiber membrane cartridges (Circe Biomedical HepatAssist(r), Vitagen ELADTM, Gerlach BELS, and Excorp Medical BLSS) are currently in various stages of clinical evaluation. Comparison of the four devices shows that several unique approaches based upon the same overall system architecture are possible. Preliminary results of the Excorp Medical BLSS Phase I safety evaluation at the University of Pittsburgh, after treating four patients (F, 41, acetominophen-induced, two support periods; M, 50, Wilson's disease, one support period; F, 53, acute alcoholic hepatitis, two support periods; F, 24, chemotherapy-induced, one support period, are presented. All patients presented with hypoglycemia and transient hypotension at the start of extracorporeal perfusion. Hypoglycemia was treated by IV dextrose and the transient hypotension responded positively to IV fluid bolus. Heparin anticoagulation was used only in the second patient. No serious or adverse events were noted in the four patients. Moderate Biochemical response to support was noted in all patients. More complete characterization of the safety of the BLSS requires completion of the Phase I safety evaluation.

Risk factors, mortality, and timing of ischemic and hemorrhagic stroke with left ventricular assist devices.

Science.gov (United States)

Frontera, Jennifer A; Starling, Randall; Cho, Sung-Min; Nowacki, Amy S; Uchino, Ken; Hussain, M Shazam; Mountis, Maria; Moazami, Nader

2017-06-01

Stroke is a major cause of mortality after left ventricular assist device (LVAD) placement. Prospectively collected data of patients with HeartMate II (n = 332) and HeartWare (n = 70) LVADs from October 21, 2004, to May 19, 2015, were reviewed. Predictors of early (during index hospitalization) and late (post-discharge) ischemic and hemorrhagic stroke and association of stroke subtypes with mortality were assessed. Of 402 patients, 83 strokes occurred in 69 patients (17%; 0.14 events per patient-year [EPPY]): early ischemic stroke in 18/402 (4%; 0.03 EPPY), early hemorrhagic stroke in 11/402 (3%; 0.02 EPPY), late ischemic stroke in 25/402 (6%; 0.04 EPPY) and late hemorrhagic stroke in 29/402 (7%; 0.05 EPPY). Risk of stroke and death among patients with stroke was bimodal with highest risks immediately post-implant and increasing again 9-12 months later. Risk of death declined over time in patients without stroke. Modifiable stroke risk factors varied according to timing and stroke type, including tobacco use, bacteremia, pump thrombosis, pump infection, and hypertension (all p hemorrhagic stroke (adjusted odds ratio [aOR] 4.3, 95% confidence interval [CI] 1.0-17.8, p = 0.04), late ischemic stroke (aOR 3.2, 95% CI 1.1-9.0, p = 0.03), and late hemorrhagic stroke (aOR 3.7, 95% CI 1.5-9.2, p = 0.005) predicted death, whereas early ischemic stroke did not. Stroke is a leading cause and predictor of death in patients with LVADs. Risk of stroke and death among patients with stroke is bimodal, with highest risk at time of implant and increasing risk again after 9-12 months. Management of modifiable risk factors may reduce stroke and mortality rates. Copyright © 2017 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Fiber Bragg grating sensor-based communication assistance device

Science.gov (United States)

Padma, Srivani; Umesh, Sharath; Pant, Shweta; Srinivas, Talabattula; Asokan, Sundarrajan

2016-08-01

Improvements in emergency medicine in the form of efficient life supporting systems and intensive care have increased the survival rate in critically injured patients; however, in some cases, severe brain and spinal cord injuries can result in a locked-in syndrome or other forms of paralysis, and communication with these patients may become restricted or impossible. The present study proposes a noninvasive, real-time communication assistive methodology for those with restricted communication ability, employing a fiber Bragg grating (FBG) sensor. The communication assistive methodology comprises a breath pattern analyzer using an FBG sensor, which acquires the exhalation force that is converted into strain variations on a cantilever. The FBG breath pattern analyzer along with specific breath patterns, which are programmed to give specific audio output commands, constitutes the proposed fiber Bragg grating sensor-based communication assistive device. The basic communication can be carried out by instructing the patients with restricted communication ability to perform the specific breath patterns. The present approach is intended to be an alternative to the common approach of brain-computer interface in which an instrument is utilized for learning of brain responses.

Initial in vitro testing of a paediatric continuous-flow total artificial heart.

Science.gov (United States)

Fukamachi, Kiyotaka; Karimov, Jamshid H; Horvath, David J; Sunagawa, Gengo; Byram, Nicole A; Kuban, Barry D; Moazami, Nader

2018-06-01

Mechanical circulatory support has become standard therapy for adult patients with end-stage heart failure; however, in paediatric patients with congenital heart disease, the options for chronic mechanical circulatory support are limited to paracorporeal devices or off-label use of devices intended for implantation in adults. Congenital heart disease and cardiomyopathy often involve both the left and right ventricles; in such cases, heart transplantation, a biventricular assist device or a total artificial heart is needed to adequately sustain both pulmonary and systemic circulations. We aimed to evaluate the in vitro performance of the initial prototype of our paediatric continuous-flow total artificial heart. The paediatric continuous-flow total artificial heart pump was downsized from the adult continuous-flow total artificial heart configuration by a scale factor of 0.70 (1/3 of total volume) to enable implantation in infants. System performance of this prototype was evaluated using the continuous-flow total artificial heart mock loop set to mimic paediatric circulation. We generated maps of pump performance and atrial pressure differences over a wide range of systemic vascular resistance/pulmonary vascular resistance and pump speeds. Performance data indicated left pump flow range of 0.4-4.7 l/min at 100 mmHg delta pressure. The left/right atrial pressure difference was maintained within ±5 mmHg with systemic vascular resistance/pulmonary vascular resistance ratios between 1.4 and 35, with/without pump speed modulation, verifying expected passive self-regulation of atrial pressure balance. The paediatric continuous-flow total artificial heart prototype met design requirements for self-regulation and performance; in vivo pump performance studies are ongoing.

Continuous-flow cardiac assistance : effects on aortic valve function in a mock loop

NARCIS (Netherlands)

Tuzun, E.; Rutten, M.C.M.; Dat, M.; Kadipasaoglu, C.; Vosse, van de F.N.; Mol, de B.A.J.M.

2011-01-01

Background As the use of left ventricular assist devices (LVADs) to treat end-stage heart failure has become more widespread, leaflet fusion—with resul-tant aortic regurgitation—has been observed more frequently. To quantitatively assess the effects of nonpulsatile flow on aortic valve function, we

Reproducibility for Heart Rate Variability Analysis during 6-Min Walk Test in Patients with Heart Failure and Agreement between Devices.

Science.gov (United States)

Braga, Lays Magalhães; Prado, Gustavo Faibischew; Umeda, Iracema Ioco Kikuchi; Kawauchi, Tatiana Satie; Taboada, Adriana Marques Fróes; Azevedo, Raymundo Soares; Pereira Filho, Horacio Gomes; Grupi, César José; Souza, Hayala Cristina Cavenague; Moreira, Dalmo Antônio Ribeiro; Nakagawa, Naomi Kondo

2016-01-01

Heart rate variability (HRV) analysis is a useful method to assess abnormal functioning in the autonomic nervous system and to predict cardiac events in patients with heart failure (HF). HRV measurements with heart rate monitors have been validated with an electrocardiograph in healthy subjects but not in patients with HF. We explored the reproducibility of HRV in two consecutive six-minute walk tests (6MW), 60-minute apart, using a heart rate monitor (PolarS810i) and a portable electrocardiograph (called Holter) in 50 HF patients (mean age 59 years, NYHA II, left ventricular ejection fraction ~35%). The reproducibility for each device was analysed using a paired t-test or the Wilcoxon signed-rank test. Additionally, we assessed the agreement between the two devices based on the HRV indices at rest, during the 6MW and during recovery using concordance correlation coefficients (CCC), 95% confidence intervals and Bland-Altman plots. The test-retest for the HRV analyses was reproducible using Holter and PolarS810i at rest but not during recovery. In the second 6MW, patients showed significant increases in rMSSD and walking distance. The PolarS810i measurements had remarkably high concordance correlation [0.86

Design, analysis, and testing of a flexure-based vibration-assisted polishing device

Science.gov (United States)

Gu, Yan; Zhou, Yan; Lin, Jieqiong; Lu, Mingming; Zhang, Chenglong; Chen, Xiuyuan

2018-05-01

A vibration-assisted polishing device (VAPD) composed of leaf-spring and right-circular flexure hinges is proposed with the aim of realizing vibration-assisted machining along elliptical trajectories. To design the structure, energy methods and the finite-element method are used to calculate the performance of the proposed VAPD. An improved bacterial foraging optimization algorithm is used to optimize the structural parameters. In addition, the performance of the VAPD is tested experimentally. The experimental results indicate that the maximum strokes of the two directional mechanisms operating along the Z1 and Z2 directions are 29.5 μm and 29.3 μm, respectively, and the maximum motion resolutions are 10.05 nm and 10.01 nm, respectively. The maximum working bandwidth is 1,879 Hz, and the device has a good step response.

TongueToSpeech (TTS): Wearable wireless assistive device for augmented speech.

Science.gov (United States)

Marjanovic, Nicholas; Piccinini, Giacomo; Kerr, Kevin; Esmailbeigi, Hananeh

2017-07-01

Speech is an important aspect of human communication; individuals with speech impairment are unable to communicate vocally in real time. Our team has developed the TongueToSpeech (TTS) device with the goal of augmenting speech communication for the vocally impaired. The proposed device is a wearable wireless assistive device that incorporates a capacitive touch keyboard interface embedded inside a discrete retainer. This device connects to a computer, tablet or a smartphone via Bluetooth connection. The developed TTS application converts text typed by the tongue into audible speech. Our studies have concluded that an 8-contact point configuration between the tongue and the TTS device would yield the best user precision and speed performance. On average using the TTS device inside the oral cavity takes 2.5 times longer than the pointer finger using a T9 (Text on 9 keys) keyboard configuration to type the same phrase. In conclusion, we have developed a discrete noninvasive wearable device that allows the vocally impaired individuals to communicate in real time.

Implantable Medical Devices

Science.gov (United States)

... Artery Disease Venous Thromboembolism Aortic Aneurysm More Implantable Medical Devices Updated:Sep 16,2016 For Rhythm Control ... a Heart Attack Introduction Medications Surgical Procedures Implantable Medical Devices • Life After a Heart Attack • Heart Attack ...

Automatic Emboli Detection System for the Artificial Heart

Science.gov (United States)

Steifer, T.; Lewandowski, M.; Karwat, P.; Gawlikowski, M.

In spite of the progress in material engineering and ventricular assist devices construction, thromboembolism remains the most crucial problem in mechanical heart supporting systems. Therefore, the ability to monitor the patient's blood for clot formation should be considered an important factor in development of heart supporting systems. The well-known methods for automatic embolus detection are based on the monitoring of the ultrasound Doppler signal. A working system utilizing ultrasound Doppler is being developed for the purpose of flow estimation and emboli detection in the clinical artificial heart ReligaHeart EXT. Thesystem will be based on the existing dual channel multi-gate Doppler device with RF digital processing. A specially developed clamp-on cannula probe, equipped with 2 - 4 MHz piezoceramic transducers, enables easy system setup. We present the issuesrelated to the development of automatic emboli detection via Doppler measurements. We consider several algorithms for the flow estimation and emboli detection. We discuss their efficiency and confront them with the requirements of our experimental setup. Theoretical considerations are then met with preliminary experimental findings from a) flow studies with blood mimicking fluid and b) in-vitro flow studies with animal blood. Finally, we discuss some more methodological issues - we consider several possible approaches to the problem of verification of the accuracy of the detection system.

Cross-cultural adaptation of the assistive technology device - Predisposition assessment (ATD PA) for use in Brazil (ATD PA Br).

Science.gov (United States)

Alves, Ana Cristina de Jesus; Matsukura, Thelma Simões; Scherer, Marcia J

2017-02-01

The purpose of this study is to conduct a cross-cultural adaptation of the Assistive Technology Device Predisposition Assessment (ATD PA) for use in Brazil. The selection of the Assistive Technology Device Predisposition Assessment (ATD PA) was determined by previous literature reviews of articles published in 2014 and 2016 in six databases with the terms "assistive device" or "assistive technology" or "self-help device" combined with "evidence-based practice" or "framework" or "measurement scale" or "model and outcome assessment". This review indicated that the conceptual model of Assistive Technology (AT) most discussed in the literature was the Matching Person and Technology (MPT) model, and this finding determined the selection of ATD PA as an assessment within the MPT portfolio of measures. The procedures for cross-cultural adaptation were as follows: Equivalence of Concept, Semantic and Operational. Five experts were asked to translate 725 items and these translations were evaluated and a high level of agreement was demonstrated. The Portuguese version, Avaliação de Tecnologia Assistiva - Predisposição ao Uso - ATD PA Br, was derived from the original version in English (ATD PA). The ATD PA Br will support professionals and people with disabilities in Brazil to better select AT devices according to the clients' needs. Implications for rehabilitation Provides a systematic way of selecting assistive technology devices for the use of individuals with disabilities according to the Brazilian reality. A systematic way of selecting the assistive technology that can help decrease the abandonment of the assistive technology use. The use of the Matching Person and Technology theorical model and of the assessment ATD PA Br is essential to guide the researches and clinical practice in Brazil.

A Systematic Review on Existing Measures for the Subjective Assessment of Rehabilitation and Assistive Robot Devices

Directory of Open Access Journals (Sweden)

Yiannis Koumpouros

2016-01-01

Full Text Available The objective of the current study is to identify and classify outcome measures currently used for the assessment of rehabilitation or assistive robot devices. We conducted a systematic review of the literature using PubMed, MEDLINE, CIRRIE, and Scopus databases for studies that assessed rehabilitation or assistive robot devices from 1980 through January 2016. In all, 31 articles met all inclusion criteria. Tailor-made questionnaires were the most commonly used tool at 66.7%, while the great majority (93.9% of the studies used nonvalidated instruments. The study reveals the absence of a standard scale which makes it difficult to compare the results from different researchers. There is a great need, therefore, for a valid and reliable instrument to be available for use by the intended end users for the subjective assessment of robot devices. The study concludes by identifying two scales that have been validated in general assistive technology devices and could support the scope of subjective assessment in rehabilitation or assistive robots (however, with limited coverage and a new one called PYTHEIA, recently published. The latter intends to close the gap and help researchers and developers to evaluate, assess, and produce products that satisfy the real needs of the end users.

Exploring cognitive bias in destination therapy left ventricular assist device decision making: A retrospective qualitative framework analysis.

Science.gov (United States)

Magid, Molly; McIlvennan, Colleen K; Jones, Jaqueline; Nowels, Carolyn T; Allen, Larry A; Thompson, Jocelyn S; Matlock, Dan

2016-10-01

Cognitive biases are psychological influences, which cause humans to make decisions, which do not seemingly maximize utility. For people with heart failure, the left ventricular assist device (LVAD) is a surgically implantable device with complex tradeoffs. As such, it represents an excellent model within which to explore cognitive bias in a real-world decision. We conducted a framework analysis to examine for evidence of cognitive bias among people deciding whether or not to get an LVAD. The aim of this study was to explore the influence of cognitive bias on the LVAD decision-making process. We analyzed previously conducted interviews of patients who had either accepted or declined an LVAD using a deductive, predetermined framework of cognitive biases. We coded and analyzed the interviews using an inductive-deductive framework approach, which also allowed for other themes to emerge. We interviewed a total of 22 heart failure patients who had gone through destination therapy LVAD decision making (15 who had accepted the LVAD and 7 who had declined). All patients appeared influenced by state dependence, where both groups described high current state of suffering, but the groups differed in whether they believed LVAD would relieve suffering or not. We found evidence of cognitive bias that appeared to influence decision making in both patient groups, but groups differed in terms of which cognitive biases were present. Among accepters, we found evidence of anchoring bias, availability bias, optimism bias, and affective forecasting. Among decliners, we found evidence of errors in affective forecasting. Medical decision making is often a complicated and multifaceted process that includes cognitive bias as well as other influences. It is important for clinicians to recognize that patients can be affected by cognitive bias, so they can better understand and improve the decision-making process to ensure that patients are fully informed. Published by Elsevier Inc.

When withdrawal of life-sustaining care does more than allow death to take its course: the dilemma of left ventricular assist devices.

Science.gov (United States)

Bramstedt, K A; Wenger, N S

2001-05-01

Left ventricular assist devices (LVADs) are a relatively new technology that is increasingly used to preserve cardiac function. These devices work by a mechanism that may complicate ethical decision-making for patients who subsequently lose decision-making capacity and are no longer considered transplant candidates. Using a clinical case from our medical center, we explored the complex ethical issues associated with the discontinuation of LVAD therapy by discussing how this device is distinct from the withdrawal of other treatments. While halting an implanted LVAD may permit a patient to die, the deactivated device itself may contribute to patient death due to the potential for blood backflow and pooling, as well as the disruption of heart contractility. Inadequate informed consent and failure to appoint a surrogate decision-maker in advance of the implant procedure resulted in a complex ethical dilemma for the patient's family and the medical team. Clinicians and families must consider the benefits and burdens of LVAD therapy as they do when considering removal of other life-sustaining treatment. The informed consent process associated with LVADs as bridging technology should include extensive consideration of the purpose of the device, future circumstances in which it may be halted, and how such situations would be recognized and handled. Appointment of a surrogate decision-maker before the surgical procedure is essential.

Development and evaluation of a Stirling-powered cardiac assist system. Annual report, May 1974--Jul 1975

International Nuclear Information System (INIS)

Andrus, S.; Faeser, R.J.; Moise, J.; Hoffman, L.C.; Rudnicki, M.I.

1975-09-01

The Stirling-Cycle engine is designed to power implantable physiologically compatible heart-assist and total heart replacement devices. Heat is provided by a 238 Pu radioisotope capsule. Program activity during this report period included the development of the PAC-5 and PAC-5M actuators and the MK-VII engine. The report describes extensive endurance and accelerated life testing of complete LVAD systems and individual components

A wound retraction device for laparoscopic-assisted intestinal surgery in dogs and cats.

Science.gov (United States)

Gower, Sara B; Mayhew, Philipp D

2011-06-01

To report experience with laparoscopic-assisted intestinal resection and anastomosis for treatment of discrete intestinal masses using a novel wound retraction device. Case series. Dogs (n=2) and cats (6). Dogs and cats with discrete intestinal masses identified by ultrasonography without evidence of intestinal perforation or peritonitis, were included. A 2 portal technique was used; 1 portal was enlarged for insertion of the wound retraction device through which the intestine was examined as thoroughly as possible. The diseased portion of the intestine was exteriorized through the wound retractor and resection and anastomosis of the intestinal mass performed. Of the 8 animals, laparoscopic-assisted intestinal resection and anastomosis through the wound retractor was performed in 2 dogs and 3 cats. In 3 cats, based on either location or extent of the lesion, 2 were converted to laparoscopic-assisted intestinal biopsies and 1 to an open colocolostomy. No other intra- or perioperative complications were encountered and all animals survived to discharge. Laparoscopic-assisted intestinal resection and anastomosis can be performed in select canine and feline patients with modestly sized, discrete intestinal masses. © Copyright 2011 by The American College of Veterinary Surgeons.

49 CFR 39.93 - What wheelchairs and other assistive devices may passengers with a disability bring onto a...

Science.gov (United States)

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What wheelchairs and other assistive devices may passengers with a disability bring onto a passenger vessel? 39.93 Section 39.93 Transportation Office of the... and Services to Passengers With Disabilities § 39.93 What wheelchairs and other assistive devices may...

Impact of Socioeconomic Status on Patients Supported With a Left Ventricular Assist Device: An Analysis of the UNOS Database (United Network for Organ Sharing).

Science.gov (United States)

Clerkin, Kevin J; Garan, Arthur Reshad; Wayda, Brian; Givens, Raymond C; Yuzefpolskaya, Melana; Nakagawa, Shunichi; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Mancini, Donna M; Colombo, Paolo C; Topkara, Veli K

2016-10-01

Low socioeconomic status (SES) is a known risk factor for heart failure, mortality among those with heart failure, and poor post heart transplant (HT) outcomes. This study sought to determine whether SES is associated with decreased waitlist survival while on left ventricular assist device (LVADs) support and after HT. A total of 3361 adult patients bridged to primary HT with an LVAD between May 2004 and April 2014 were identified in the UNOS database (United Network for Organ Sharing). SES was measured using the Agency for Healthcare Research and Quality SES index using data from the 2014 American Community Survey. In the study cohort, SES did not have an association with the combined end point of death or delisting on LVAD support (P=0.30). In a cause-specific unadjusted model, those in the top (hazard ratio, 1.55; 95% confidence interval, 1.14-2.11; P=0.005) and second greatest SES quartile (hazard ratio 1.50; 95% confidence interval, 1.10-2.04; P=0.01) had an increased risk of death on device support compared with the lowest SES quartile. Adjusting for clinical risk factors mitigated the increased risk. There was no association between SES and complications. Post-HT survival, both crude and adjusted, was decreased for patients in the lowest quartile of SES index compared with all other SES quartiles. Freedom from waitlist death or delisting was not affected by SES. Patients with a higher SES had an increased unadjusted risk of waitlist mortality during LVAD support, which was mitigated by adjusting for increased comorbid conditions. Low SES was associated with worse post-HT outcomes. Further study is needed to confirm and understand a differential effect of SES on post-transplant outcomes that was not seen during LVAD support before HT. © 2016 American Heart Association, Inc.

Experimental Assessment of the Hydraulics of a Miniature Axial-Flow Left Ventricular Assist Device

Science.gov (United States)

Smith, P. Alex; Cohn, William; Metcalfe, Ralph

2017-11-01

A minimally invasive partial-support left ventricular assist device (LVAD) has been proposed with a flow path from the left atrium to the arterial system to reduce left ventricular stroke work. In LVAD design, peak and average efficiency must be balanced over the operating range to reduce blood trauma. Axial flow pumps have many geometric parameters. Until recently, testing all these parameters was impractical, but modern 3D printing technology enables multi-parameter studies. Following theoretical design, experimental hydraulic evaluation in steady state conditions examines pressure, flow, pressure-flow gradient, efficiency, torque, and axial force as output parameters. Preliminary results suggest that impeller blades and stator vanes with higher inlet angles than recommended by mean line theory (MLT) produce flatter gradients and broader efficiency curves, increasing compatibility with heart physiology. These blades also produce less axial force, which reduces bearing load. However, they require slightly higher torque, which is more demanding of the motor. MLT is a low order, empirical model developed on large pumps. It does not account for the significant viscous losses in small pumps like LVADs. This emphasizes the importance of experimental testing for hydraulic design. Roderick D MacDonald Research Fund.

Extraction of the Electric Field in Field Plate Assisted RESURF Devices

NARCIS (Netherlands)

Boksteen, B.K.; Dhar, S.; Heringa, A.; Koops, G.E.J.; Hueting, Raymond Josephus Engelbart

2012-01-01

It has previously been reported that the lateral electric field (Ex) in the drain extension of thin SOI HV (700V) field plate assisted RESURF devices can be extracted from their ID-VD characteristics in the subthreshold regime. In this work the prerequisites for valid field extraction and the

The Achilles' heel of left ventricular assist device therapy: right ventricle.

Science.gov (United States)

Ranganath, Neel K; Smith, Deane E; Moazami, Nader

2018-06-01

Many patients suffer from either persistent right ventricular failure (RVF) at the time of left ventricular assist device (LVAD) or have ongoing symptoms consistent with RVF during chronic mechanical circulatory support. The lack of long-term right ventricular assist devices (RVADs) has limited the impact that mechanical circulatory support can provide to patients with biventricular failure. We aim to review the entire spectrum of RVF in patients receiving LVADs and reflect on why this entity remains the Achilles' heel of LVAD therapy. In the early postoperative period, LVAD implantation reduces right ventricle (RV) afterload, but RV dysfunction may be exacerbated secondary to increased venous return. With prolonged therapy, the decreased RV afterload leads to improved RV contractile function. Bayesian statistical models outperform previously published preoperative risk scores by considering inter-relationships and conditional probabilities amongst independent variables. Various echocardiographic parameters and the pulmonary artery pulsatility index have shown promise in predicting post-LVAD RVF. Recent publications have delineated the emergence of 'delayed' RVF. Several devices are currently being investigated for use as RVADs. Post-LVAD RVF depends on the RV's ability to adapt to acute hemodynamic changes imposed by the LVAD. Management options are limited due to the lack of an easily implantable, chronic-use RVAD.

Ab initio assisted process modeling for Si-based nanoelectronic devices

International Nuclear Information System (INIS)

Windl, Wolfgang

2005-01-01

In this paper, we discuss concepts and examples of ab initio calculations assisting physics-based process simulation. We focus on how to determine diffusion and reaction constants, where modern methods such as the nudged elastic band method allow a systematic and reliable search for the minimum energy migration path and barrier. We show that once the saddle point is determined, the underlying harmonic transition state theory also allows to calculate the prefactors. The discussed examples include nitrogen diffusion, boron deactivation and boron interface segregation. Finally, some concepts are discussed for future device technologies such as molecular devices, where the currently prevalent multiscale approach (kinetic parameters used in higher level models like diffusion-reaction or kinetic Monte Carlo modeling) would not be sensible anymore. As an example, we described the ab initio temperature-accelerated dynamics modeling of contact formation in carbon nanotube devices

Wireless sEMG-Based Body-Machine Interface for Assistive Technology Devices.

Science.gov (United States)

Fall, Cheikh Latyr; Gagnon-Turcotte, Gabriel; Dube, Jean-Francois; Gagne, Jean Simon; Delisle, Yanick; Campeau-Lecours, Alexandre; Gosselin, Clement; Gosselin, Benoit

2017-07-01

Assistive technology (AT) tools and appliances are being more and more widely used and developed worldwide to improve the autonomy of people living with disabilities and ease the interaction with their environment. This paper describes an intuitive and wireless surface electromyography (sEMG) based body-machine interface for AT tools. Spinal cord injuries at C5-C8 levels affect patients' arms, forearms, hands, and fingers control. Thus, using classical AT control interfaces (keypads, joysticks, etc.) is often difficult or impossible. The proposed system reads the AT users' residual functional capacities through their sEMG activity, and converts them into appropriate commands using a threshold-based control algorithm. It has proven to be suitable as a control alternative for assistive devices and has been tested with the JACO arm, an articulated assistive device of which the vocation is to help people living with upper-body disabilities in their daily life activities. The wireless prototype, the architecture of which is based on a 3-channel sEMG measurement system and a 915-MHz wireless transceiver built around a low-power microcontroller, uses low-cost off-the-shelf commercial components. The embedded controller is compared with JACO's regular joystick-based interface, using combinations of forearm, pectoral, masseter, and trapeze muscles. The measured index of performance values is 0.88, 0.51, and 0.41 bits/s, respectively, for correlation coefficients with the Fitt's model of 0.75, 0.85, and 0.67. These results demonstrate that the proposed controller offers an attractive alternative to conventional interfaces, such as joystick devices, for upper-body disabled people using ATs such as JACO.

Integrating medical, assistive, and universally designed products and technologies: assistive technology device classification (ATDC).

Science.gov (United States)

Bauer, Stephen; Elsaesser, Linda-Jeanne

2012-09-01

ISO26000:2010 International Guidance Standard on Organizational Social Responsibility requires that effective organizational performance recognize social responsibility, including the rights of persons with disabilities (PWD), engage stakeholders and contribute to sustainable development. Millennium Development Goals 2010 notes that the most vulnerable people require special attention, while the World Report on Disability 2011 identifies improved data collection and removal of barriers to rehabilitation as the means to empower PWD. The Assistive Technology Device Classification (ATDC), Assistive Technology Service Method (ATSM) and Matching Person and Technology models provide an evidence-based, standardized, internationally comparable framework to improve data collection and rehabilitation interventions. The ATDC and ATSM encompass and support universal design (UD) principles, and use the language and concepts of the International Classification of Functioning, Disability and Health (ICF). Use ATDC and ICF concepts to differentiate medical, assistive and UD products and technology; relate technology "types" to markets and costs; and support provision of UD products and technologies as sustainable and socially responsible behavior. Supply-side and demand-side incentives are suggested to foster private sector development and commercialization of UD products and technologies. Health and health-related professionals should be knowledgeable of UD principles and interventions.

[Intelligent operating room suite : From passive medical devices to the self-thinking cognitive surgical assistant].

Science.gov (United States)

Kenngott, H G; Wagner, M; Preukschas, A A; Müller-Stich, B P

2016-12-01

Modern operating room (OR) suites are mostly digitally connected but until now the primary focus was on the presentation, transfer and distribution of images. Device information and processes within the operating theaters are barely considered. Cognitive assistance systems have triggered a fundamental rethinking in the automotive industry as well as in logistics. In principle, tasks in the OR, some of which are highly repetitive, also have great potential to be supported by automated cognitive assistance via a self-thinking system. This includes the coordination of the entire workflow in the perioperative process in both the operating theater and the whole hospital. With corresponding data from hospital information systems, medical devices and appropriate models of the surgical process, intelligent systems could optimize the workflow in the operating theater in the near future and support the surgeon. Preliminary results on the use of device information and automatically controlled OR suites are already available. Such systems include, for example the guidance of laparoscopic camera systems. Nevertheless, cognitive assistance systems that make use of knowledge about patients, processes and other pieces of information to improve surgical treatment are not yet available in the clinical routine but are urgently needed in order to automatically assist the surgeon in situation-related activities and thus substantially improve patient care.

Validity and reliability of a novel slow cuff-deflation system for noninvasive blood pressure monitoring in patients with continuous-flow left ventricular assist device.

Science.gov (United States)

Lanier, Gregg M; Orlanes, Khristine; Hayashi, Yacki; Murphy, Jennifer; Flannery, Margaret; Te-Frey, Rosie; Uriel, Nir; Yuzefpolskaya, Melana; Mancini, Donna M; Naka, Yoshifumi; Takayama, Hiroo; Jorde, Ulrich P; Demmer, Ryan T; Colombo, Paolo C

2013-09-01

Doppler ultrasound is the clinical gold standard for noninvasive blood pressure (BP) measurement among continuous-flow left ventricular assist device patients. The relationship of Doppler BP to systolic BP (SBP) and mean arterial pressure (MAP) is uncertain and Doppler measurements require a clinic visit. We studied the relationship between Doppler BP and both arterial-line (A-line) SBP and MAP. Validity and reliability of the Terumo Elemano BP Monitor, a novel slow cuff-deflation device that could potentially be used by patients at home, were assessed. Doppler and Terumo BP measurements were made in triplicate among 60 axial continuous-flow left ventricular assist device (HeartMate II) patients (30 inpatients and 30 outpatients) at 2 separate exams (360 possible measurements). A-line measures were also obtained among inpatients. Mean absolute differences (MADs) and correlations were used to determine within-device reliability (comparison of second and third BP measures) and between-device validity. Bland-Altman plots assessed BP agreement between A-line, Doppler BP, and Terumo Elemano. Success rates for Doppler and Terumo Elemano were 100% and 91%. Terumo Elemano MAD for repeat SBP and MAP were 4.6±0.6 and 4.2±0.6 mm Hg; repeat Doppler BP MAD was 2.9±0.2 mm Hg. Mean Doppler BP was lower than A-line SBP by 4.1 (MAD=6.4±1.4) mm Hg and higher than MAP by 9.5 (MAD=11.0±1.2) mm Hg; Terumo Elemano underestimated A-line SBP by 0.3 (MAD=5.6±0.9) mm Hg and MAP by 1.7 (MAD=6.0±1.0) mm Hg. Doppler BP more closely approximates SBP than MAP. Terumo Elemano was successful, reliable, and valid when compared with A-line and Doppler.

Inhaled Milrinone After Left Ventricular Assist Device Implantation.

Science.gov (United States)

Haglund, Nicholas A; Burdorf, Adam; Jones, Tara; Shostrom, Valerie; Um, John; Ryan, Timothy; Shillcutt, Sasha; Fischer, Patricia; Cox, Zachary L; Raichlin, Eugenia; Anderson, Daniel R; Lowes, Brian D; Dumitru, Ioana

2015-10-01

Proven strategies to reduce right ventricular (RV) dysfunction after continuous-flow left ventricular assist device (CF-LVAD) implantation are lacking. We sought to evaluate the tolerability, feasibility, efficacy, and pharmacokinetics of inhaled milrinone (iMil) delivery after CF-LVAD implantation. We prospectively evaluated fixed-dose nebulized iMil delivered into a ventilator circuit for 24 hours in 10 postoperative CF-LVAD (Heartmate-II) patients. Tolerability (arrhythmias, hypotension, and hypersensitivity reaction), efficacy (hemodynamics), pharmacokinetics (plasma milrinone levels), and cost data were collected.Mean age was 56 ± 9 years, 90% were male, and mean INTERMACS profile was 2.5 ± 0.8. No new atrial arrhythmia events occurred, although 3 (30%) ventricular tachycardia (1 nonsustained, 2 sustained) events occurred. Sustained hypotension, drug hypersensitivity, death, or need for right ventricular assist device were not observed. Invasive mean pulmonary arterial pressure from baseline to during iMil therapy was improved (P = .017). Mean plasma milrinone levels (ng/mL) at baseline, and 1, 4, 8, 12, and 24 hours were 74.2 ± 35.4, 111.3 ± 70.9, 135.9 ± 41.5, 205.0 ± 86.7, 176.8 ± 61.3 187.6 ± 105.5, respectively. Reduced institutional cost was observed when iMil was compared with nitric oxide therapy over 24 hours ($165.29 vs $1,944.00, respectively). iMil delivery after CF-LVAD implantation was well tolerated, feasible, and demonstrated favorable hemodynamic, pharmacokinetic, and cost profiles. iMil therapy warrants further study in larger clinical trials. Copyright © 2015 Elsevier Inc. All rights reserved.

Role of long-term mechanical circulatory support in patients with advanced heart failure.

Science.gov (United States)

Stokes, M B; Bergin, P; McGiffin, D

2016-05-01

Advanced heart failure represents a small proportion of patients with heart failure that possess high-risk features associated with high hospital readmission rates, significant functional impairment and mortality. Identification of those who have progressed to, or are near a state of advanced heart failure should prompt referral to a service that offers therapies in mechanical circulatory support (MCS) and cardiac transplantation. MCS has grown as a management strategy in the care of these patients, most commonly as a bridge to cardiac transplantation. The predominant utilisation of MCS is implantation of left ventricular assist devices (LVAD), which have evolved significantly in their technology and application over the past 15-20 years. The technology has evolved to such an extent that Destination Therapy is now being utilised as a strategy in management of advanced heart failure in appropriately selected patients. Complication rates have decreased with VAD implantation, but remain a significant consideration in the decision to implant a device, and in the follow up of these patients. © 2016 Royal Australasian College of Physicians.

Partial LVAD restores ventricular outputs and normalizes LV but not RV stress distributions in the acutely failing heart in silico

OpenAIRE

Sack, Kevin L.; Baillargeon, Brian; Acevedo-Bolton, Gabriel; Genet, Martin; Rebelo, Nuno; Kuhl, Ellen; Klein, Liviu; Weiselthaler, Georg M.; Burkhoff, Daniel; Franz, Thomas; Guccione, Julius M.

2016-01-01

Purpose: Heart failure is a worldwide epidemic that is unlikely to change as the population ages and life expectancy increases. We sought to detail significant recent improvements to the Dassault Systèmes Living Heart Model (LHM) and use the LHM to compute left ventricular (LV) and right ventricular (RV) myofiber stress distributions under the following 4 conditions: (1) normal cardiac function; (2) acute left heart failure (ALHF); (3) ALHF treated using an LV assist device (LVAD) flow rate o...

Metabolic volume performs better than SUVmax in the detection of left ventricular assist device driveline infection

Energy Technology Data Exchange (ETDEWEB)

Avramovic, Nemanja; Weckesser, Matthias; Milankovic, Danka; Vrachimis, Alexis; Wenning, Christian [University Hospital Muenster, Department of Nuclear Medicine, Muenster (Germany); Dell' Aquila, Angelo Maria; Sindermann, Juergen R. [University Hospital Muenster, Department of Cardiac Surgery, Muenster (Germany)

2017-10-15

A continuous-flow left ventricular assist device (LVAD) is a new and highly promising therapy in supporting end-stage heart failure patients, either bridging them to heart transplantation or as a destination therapy. Infection is one of the major complications associated with LVAD implants. {sup 18}F-FDG PET/CT has already been shown to be useful in the detection of LVAD infection. The goal of this study was to compare the diagnostic accuracy of different PET analysis techniques (visual grading versus SUVmax and metabolic volume). We retrospectively analyzed 48 patients with implanted LVAD who underwent an {sup 18}F-FDG PET/CT that were either suspected to have a driveline or device infection or inflammation of unknown origin. PET/CT was analyzed qualitatively (visual grading) and quantitatively (SUVmax and metabolic volume) and matched to the final clinical diagnosis concerning driveline infection. The final diagnosis (standard of reference) was made at the end of clinically recorded follow-up or transplantation and included microbiological cultures of the driveline exit site and/or surgical samples, and clinical signs of infection despite negative cultures as well as recurrence of symptoms. Sensitivity, specificity, positive and negative predictive value were 87.5%, 79%, 81% and 86% for visual score, 87.5%, 87.5%, 87.5% and 87.5% for SUVmax and 96%, 87.5%, 88.5%, 95.5% for metabolic volume, respectively. ROC analysis revealed an AUC of.929 for SUVmax and.969 for metabolic volume. Both SUVmax and metabolic volume had a high detection rate of patients with driveline infection (21/24 = 91.5% true positive vs. 23/26 = 88.5% true positive, respectively). However, metabolic volume detected more patients without any infection correctly (1/22 = 4.5% false negative vs. 3/24 = 12.5% false negative). {sup 18}F-FDG PET/CT is a valuable tool for the diagnosis of LVAD driveline infection with high diagnostic accuracy. Particularly the use of the metabolic volume yields very

The pathophysiology of heart failure.

Science.gov (United States)

Kemp, Clinton D; Conte, John V

2012-01-01

Heart failure is a clinical syndrome that results when the heart is unable to provide sufficient blood flow to meet metabolic requirements or accommodate systemic venous return. This common condition affects over 5 million people in the United States at a cost of $10-38 billion per year. Heart failure results from injury to the myocardium from a variety of causes including ischemic heart disease, hypertension, and diabetes. Less common etiologies include cardiomyopathies, valvular disease, myocarditis, infections, systemic toxins, and cardiotoxic drugs. As the heart fails, patients develop symptoms which include dyspnea from pulmonary congestion, and peripheral edema and ascites from impaired venous return. Constitutional symptoms such as nausea, lack of appetite, and fatigue are also common. There are several compensatory mechanisms that occur as the failing heart attempts to maintain adequate function. These include increasing cardiac output via the Frank-Starling mechanism, increasing ventricular volume and wall thickness through ventricular remodeling, and maintaining tissue perfusion with augmented mean arterial pressure through activation of neurohormonal systems. Although initially beneficial in the early stages of heart failure, all of these compensatory mechanisms eventually lead to a vicious cycle of worsening heart failure. Treatment strategies have been developed based upon the understanding of these compensatory mechanisms. Medical therapy includes diuresis, suppression of the overactive neurohormonal systems, and augmentation of contractility. Surgical options include ventricular resynchronization therapy, surgical ventricular remodeling, ventricular assist device implantation, and heart transplantation. Despite significant understanding of the underlying pathophysiological mechanisms in heart failure, this disease causes significant morbidity and carries a 50% 5-year mortality. Copyright © 2012 Elsevier Inc. All rights reserved.

Can Wearable Devices Accurately Measure Heart Rate Variability? A Systematic Review.

Science.gov (United States)

Georgiou, Konstantinos; Larentzakis, Andreas V; Khamis, Nehal N; Alsuhaibani, Ghadah I; Alaska, Yasser A; Giallafos, Elias J

2018-03-01

A growing number of wearable devices claim to provide accurate, cheap and easily applicable heart rate variability (HRV) indices. This is mainly accomplished by using wearable photoplethysmography (PPG) and/or electrocardiography (ECG), through simple and non-invasive techniques, as a substitute of the gold standard RR interval estimation through electrocardiogram. Although the agreement between pulse rate variability (PRV) and HRV has been evaluated in the literature, the reported results are still inconclusive especially when using wearable devices. The purpose of this systematic review is to investigate if wearable devices provide a reliable and precise measurement of classic HRV parameters in rest as well as during exercise. A search strategy was implemented to retrieve relevant articles from MEDLINE and SCOPUS databases, as well as, through internet search. The 308 articles retrieved were reviewed for further evaluation according to the predetermined inclusion/exclusion criteria. Eighteen studies were included. Sixteen of them integrated ECG - HRV technology and two of them PPG - PRV technology. All of them examined wearable devices accuracy in RV detection during rest, while only eight of them during exercise. The correlation between classic ECG derived HRV and the wearable RV ranged from very good to excellent during rest, yet it declined progressively as exercise level increased. Wearable devices may provide a promising alternative solution for measuring RV. However, more robust studies in non-stationary conditions are needed using appropriate methodology in terms of number of subjects involved, acquisition and analysis techniques implied.

Modeling Users, Context and Devices for Ambient Assisted Living Environments

Science.gov (United States)

Castillejo, Eduardo; Almeida, Aitor; López-de-Ipiña, Diego; Chen, Liming

2014-01-01

The participation of users within AAL environments is increasing thanks to the capabilities of the current wearable devices. Furthermore, the significance of considering user's preferences, context conditions and device's capabilities help smart environments to personalize services and resources for them. Being aware of different characteristics of the entities participating in these situations is vital for reaching the main goals of the corresponding systems efficiently. To collect different information from these entities, it is necessary to design several formal models which help designers to organize and give some meaning to the gathered data. In this paper, we analyze several literature solutions for modeling users, context and devices considering different approaches in the Ambient Assisted Living domain. Besides, we remark different ongoing standardization works in this area. We also discuss the used techniques, modeled characteristics and the advantages and drawbacks of each approach to finally draw several conclusions about the reviewed works. PMID:24643006

A novel ventricular restraint device (ASD) repetitively deliver Salvia miltiorrhiza to epicardium have good curative effects in heart failure management.

Science.gov (United States)

Naveed, Muhammad; Wenhua, Li; Gang, Wang; Mohammad, Imran Shair; Abbas, Muhammad; Liao, Xiaoqian; Yang, Mengqi; Zhang, Li; Liu, Xiaolin; Qi, Xiaoming; Chen, Yineng; Jiadi, Lv; Ye, Linlan; Zhijie, Wang; Ding, Chen Ding; Feng, Yu; Xiaohui, Zhou

2017-11-01

A novel ventricular restraint is the non-transplant surgical option for the management of an end-stage dilated heart failure (HF). To expand the therapeutic techniques we design a novel ventricular restraint device (ASD) which has the ability to deliver a therapeutic drug directly to the heart. We deliver a Traditional Chinese Medicine (TCM) Salvia miltiorrhiza (Danshen Zhusheye) through active hydraulic ventricular support drug delivery system (ASD) and we hypothesize that it will show better results in HF management than the restraint device and drug alone. SD rats were selected and divided into five groups (n=6), Normal, HF, HF+SM (IV), HF+ASD, HF+ASD+SM groups respectively. Post myocardial infarction (MI), electrocardiography (ECG) showed abnormal heart function in all groups and HF+ASD+SM group showed a significant therapeutic improvement with respect to other treatment HF, HF+ASD, and HF+SM (IV) groups on day 30. The mechanical functions of the heart such as heart rate, LVEDP, and LVSP were brought to normal when treated with ASD+SM and show significant (P valueASD+SM group animals compared with other treatment groups. Masson's Trichrome staining was used to study histopathology of cardiac myocytes and quantification of fibrosis was assessed. The large blue fibrotic area was observed in HF, HF+ASD, and HF+SM (IV) groups while HF+ASD+SM showed negligible fibrotic myocyte at the end of study period (30days). This study proves that novel ASD device augments the therapeutic effect of the drug and delivers Salvia miltiorrhiza to the cardiomyocytes significantly as well as provides additional support to the dilated ventricle by the heart failure. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

A numerical method to enhance the performance of a cam-type electric motor-driven left ventricular assist device.

Science.gov (United States)

Huang, Huan; Yang, Ming; Lu, Cunyue; Xu, Liang; Zhuang, Xiaoqi; Meng, Fan

2013-10-01

Pulsatile left ventricular assist devices (LVADs) driven by electric motors have been widely accepted as a treatment of heart failure. Performance enhancement with computer assistance for this kind of LVAD has seldom been reported. In this article, a numerical method is proposed to assist the design of a cam-type pump. The method requires an integrated model of an LVAD system, consisting of a motor, a transmission mechanism, and a cardiovascular circulation. Performance indices, that is, outlet pressure, outlet flow, and pump efficiency, were used to select the best cam profile from six candidates. A prototype pump connected to a mock circulatory loop (MCL) was used to calibrate the friction coefficient of the cam groove and preliminarily evaluate modeling accuracy. In vitro experiments show that the mean outlet pressure and flow can be predicted with high accuracy by the model, and gross geometries of the measurements can also be reproduced. Simulation results demonstrate that as the total peripheral resistance (TPR) is fixed at 1.1 mm Hg.s/mL, the two-cycle 2/3-rise profile is the best. Compared with other profiles, the maximum increases of pressure and flow indices are 75 and 76%, respectively, and the maximum efficiency increase is over 51%. For different TPRs (0.5∼1.5 mm Hg.s/mL) and operation intervals (0.1∼0.4 s) in counterpulsation, the conclusion is also acceptable. © 2013 Wiley Periodicals, Inc. and International Center for Artificial Organs and Transplantation.

Interagency registry for mechanically assisted circulatory support report on the total artificial heart.

Science.gov (United States)

Arabía, Francisco A; Cantor, Ryan S; Koehl, Devin A; Kasirajan, Vigneshwar; Gregoric, Igor; Moriguchi, Jaime D; Esmailian, Fardad; Ramzy, Danny; Chung, Joshua S; Czer, Lawrence S; Kobashigawa, Jon A; Smith, Richard G; Kirklin, James K

2018-04-26

We sought to better understand the patient population who receive a temporary total artificial heart (TAH) as bridge to transplant or as bridge to decision by evaluating data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. We examined data related to survival, adverse events, and competing outcomes from patients who received TAHs between June 2006 and April 2017 and used hazard function analysis to explore risk factors for mortality. Data from 450 patients (87% men; mean age, 50 years) were available in the INTERMACS database. The 2 most common diagnoses were dilated cardiomyopathy (50%) and ischemic cardiomyopathy (20%). Risk factors for right heart failure were present in 82% of patients. Most patients were INTERMACS Profile 1 (43%) or 2 (37%) at implantation. There were 266 patients who eventually underwent transplantation, and 162 died. Overall 3-, 6-, and 12-month actuarial survival rates were 73%, 62%, and 53%, respectively. Risk factors for death included older age (p = 0.001), need for pre-implantation dialysis (p = 0.006), higher creatinine (p = 0.008) and lower albumin (p Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

The use of mobile devices as assistive technology in resource-limited environments: access for learners with visual impairments in Kenya.

Science.gov (United States)

Foley, Alan R; Masingila, Joanna O

2015-07-01

In this paper, the authors explore the use of mobile devices as assistive technology for students with visual impairments in resource-limited environments. This paper provides initial data and analysis from an ongoing project in Kenya using tablet devices to provide access to education and independence for university students with visual impairments in Kenya. The project is a design-based research project in which we have developed and are refining a theoretically grounded intervention--a model for developing communities of practice to support the use of mobile technology as an assistive technology. We are collecting data to assess the efficacy and improve the model as well as inform the literature that has guided the design of the intervention. In examining the impact of the use of mobile devices for the students with visual impairments, we found that the devices provide the students with (a) access to education, (b) the means to participate in everyday life and (c) the opportunity to create a community of practice. Findings from this project suggest that communities of practice are both a viable and a valuable approach for facilitating the diffusion and support of mobile devices as assistive technology for students with visual impairments in resource-limited environments. Implications for Rehabilitation The use of mobile devices as assistive technology in resource-limited environments provides students with visual impairments access to education and enhanced means to participate in everyday life. Communities of practice are both a viable and a valuable approach for facilitating the diffusion and support of mobile devices as assistive technology for students with visual impairments in resource-limited environments. Providing access to assistive technology early and consistently throughout students' schooling builds both their skill and confidence and also demonstrates the capabilities of people with visual impairments to the larger society.

Worldwide Experience with the Syncardia Total Artificial Heart in the Pediatric Population.

Science.gov (United States)

Morales, David L S; Lorts, Angela; Rizwan, Raheel; Zafar, Farhan; Arabia, Francisco A; Villa, Chet R

Individual centers have documented the use of the Syncardia Total Artificial Heart (TAH) in adolescents with heart failure; however, the number of patients at any given center is small. Herein, we describe the worldwide experience for all patients ≤21 years old supported with the TAH between May 2005 and May 2015 (n = 43). The number of patients experiencing a positive outcome at 60, 90, and 120 days were 30 (70%), 27 (63%), and 25 (58%), respectively. Successful bridge to transplantation varied by diagnosis, but outcomes reported are similar to adults supported with the TAH or biventricular assist devices.

Utility of the Seattle Heart Failure Model in patients with advanced heart failure.

Science.gov (United States)

Kalogeropoulos, Andreas P; Georgiopoulou, Vasiliki V; Giamouzis, Grigorios; Smith, Andrew L; Agha, Syed A; Waheed, Sana; Laskar, Sonjoy; Puskas, John; Dunbar, Sandra; Vega, David; Levy, Wayne C; Butler, Javed

2009-01-27

The aim of this study was to validate the Seattle Heart Failure Model (SHFM) in patients with advanced heart failure (HF). The SHFM was developed primarily from clinical trial databases and extrapolated the benefit of interventions from published data. We evaluated the discrimination and calibration of SHFM in 445 advanced HF patients (age 52 +/- 12 years, 68.5% male, 52.4% white, ejection fraction 18 +/- 8%) referred for cardiac transplantation. The primary end point was death (n = 92), urgent transplantation (n = 14), or left ventricular assist device (LVAD) implantation (n = 3); a secondary analysis was performed on mortality alone. Patients were receiving optimal therapy (angiotensin-II modulation 92.8%, beta-blockers 91.5%, aldosterone antagonists 46.3%), and 71.0% had an implantable device (defibrillator 30.4%, biventricular pacemaker 3.4%, combined 37.3%). During a median follow-up of 21 months, 109 patients (24.5%) had an event. Although discrimination was adequate (c-statistic >0.7), the SHFM overall underestimated absolute risk (observed vs. predicted event rate: 11.0% vs. 9.2%, 21.0% vs. 16.6%, and 27.9% vs. 22.8% at 1, 2, and 3 years, respectively). Risk underprediction was more prominent in patients with an implantable device. The SHFM had different calibration properties in white versus black patients, leading to net underestimation of absolute risk in blacks. Race-specific recalibration improved the accuracy of predictions. When analysis was restricted to mortality, the SHFM exhibited better performance. In patients with advanced HF, the SHFM offers adequate discrimination, but absolute risk is underestimated, especially in blacks and in patients with devices. This is more prominent when including transplantation and LVAD implantation as an end point.

Magnetic suspension of the rotor of a ventricular assist device of mixed flow type.

Science.gov (United States)

Horikawa, Oswaldo; de Andrade, Aron José Pazin; da Silva, Isaías; Bock, Eduardo Guy Perpetuo

2008-04-01

This work presents results of preliminary studies concerning application of magnetic bearing in a ventricular assist device (VAD) being developed by Dante Pazzanese Institute of Cardiology-IDPC (São Paulo, Brazil). The VAD-IDPC has a novel architecture that distinguishes from other known VADs. In this, the rotor has a conical geometry with spiral impellers, showing characteristics that are intermediate between a centrifugal VAD and an axial VAD. The effectiveness of this new type of blood pumping principle was showed by tests and by using it in heart surgery for external blood circulation. However, the developed VAD uses a combination of ball bearings and mechanical seals, limiting the life for some 10 h, making impossible its long-term use or its use as an implantable VAD. As a part of development of an implantable VAD, this work aims at the replacement of ball bearings by a magnetic bearing. The most important magnetic bearing principles are studied and the magnetic bearing developed by Escola Politécnica of São Paulo University (EPUSP-MB) is elected because of its very simple architecture. Besides presenting the principle of the EPUSP-MB, this work presents one possible alternative for applying the EPUSP-MB in the IDPC-VAD.

Measuring irradiated lung and heart area in breast tangential fields using a simulator-based computerized tomography device

International Nuclear Information System (INIS)

Mallik, Raj; Fowler, Allan; Hunt, Peter

1995-01-01

Purpose: To illustrate the use of a simulator based computerized tomography system (SIMCT) in the simulation and planning of tangential breast fields. Methods and Materials: Forty-five consecutive patients underwent treatment planning using a radiotherapy simulator with computerized tomography attachment. One to three scans were obtained for each patient, calculations were made on the central axis scan. Due to the wide aperture of this system all patients were able to be scanned in the desired treatment position with arm abducted 90 deg. . Using available software tools the area of lung and/or heart included within the tangential fields was calculated. The greatest perpendicular distance (GPD) from the chest wall to posterior field edge was also measured. Results: The mean GPD for the group was 25.40 mm with 71% of patients having GPDs of ≤ 30 mm. The mean area of irradiated lung was 1780 sq mm which represented 18.0% of the total ipsilateral lung area seen in the central axis. Seven of the patients with left sided tumors had an average 1314 sq mm heart irradiated in the central axis. This represented 11.9% of total heart area in these patients. Conclusion: Measurements of irradiated lung and heart area can be easily and accurately made using a SIMCT device. Such measurements may help identify those patients potentially at risk for lung or heart toxicity as a consequence of their treatment. A major advantage of this device is the ability to scan patients in the actual treatment position

Measuring irradiated lung and heart area in breast tangential fields using a simulator-based computerized tomography device

Energy Technology Data Exchange (ETDEWEB)

Mallik, Raj; Fowler, Allan; Hunt, Peter

1995-01-15

Purpose: To illustrate the use of a simulator based computerized tomography system (SIMCT) in the simulation and planning of tangential breast fields. Methods and Materials: Forty-five consecutive patients underwent treatment planning using a radiotherapy simulator with computerized tomography attachment. One to three scans were obtained for each patient, calculations were made on the central axis scan. Due to the wide aperture of this system all patients were able to be scanned in the desired treatment position with arm abducted 90 deg. . Using available software tools the area of lung and/or heart included within the tangential fields was calculated. The greatest perpendicular distance (GPD) from the chest wall to posterior field edge was also measured. Results: The mean GPD for the group was 25.40 mm with 71% of patients having GPDs of {<=} 30 mm. The mean area of irradiated lung was 1780 sq mm which represented 18.0% of the total ipsilateral lung area seen in the central axis. Seven of the patients with left sided tumors had an average 1314 sq mm heart irradiated in the central axis. This represented 11.9% of total heart area in these patients. Conclusion: Measurements of irradiated lung and heart area can be easily and accurately made using a SIMCT device. Such measurements may help identify those patients potentially at risk for lung or heart toxicity as a consequence of their treatment. A major advantage of this device is the ability to scan patients in the actual treatment position.

Falls and Use of Assistive Devices in Stroke Patients with Hemiparesis: Association with Balance Ability and Fall Efficacy.

Science.gov (United States)

Kim, Oksoo; Kim, Jung-Hee

2015-01-01

This study investigates balance ability and the fall efficacy with regard to the experiences of stroke patients with hemiparesis. The experience of falling, the use of assistive devices, and each disease-related characteristic were assessed using face-to-face interviews and a self-reported questionnaire. The Berg Balance Scale and Fall Efficacy Scale were used to measure balance ability and confidence. The fall efficacy was significantly lower in participants who had experienced falls than those who had not. The participants who used assistive devices exhibited low balance ability and fall efficacy compared to those who did not use assistive devices. Stroke patients with fall experience and walking aids might be considered at increased risk of falling. Preventive measures for individuals using walking aids may be beneficial in reducing the fall rate of community-dwelling stroke patients. © 2014 Association of Rehabilitation Nurses.

Heart resynchronization therapy: experience, clinical Follow-up and optimization of the device with echocardiography

International Nuclear Information System (INIS)

Munera, Ana G; Restrepo, Gustavo; Duque, Mauricio; Cubides, Carlos; Uribe, William; Medina, Eduardo; Marin, Jorge; Gil, Efrain; Aristizabal, Dagnovar

2007-01-01

In patients with advanced heart failure, functional class lll-IV, mortality reaches 50% at one year and 80% at two years. Some remain asymptomatic and have a poor functional state, regardless of the pharmacologic treatment. Heart resynchronization therapy is a therapeutic alternative that improves hemodynamic and symptoms in these patients. The objective is to analyze the experience in the management of heart failure with heart resynchronization therapy devices with or without cardio defibrillator. Methodological design: an intervention study without aleatory patients assignment, with evaluation before and after the intervention. Results: the cohort was constituted by 82 patients. 73% were men. Mean age was 65.4+/- 11.9 years. The etiology was non-ischemic in 50 patients and ischemic in 32. Mean initial ejection fraction was 19.4% +/- 11.7%. Initial functional class was class lll - IV in 85% of cases and all patients received optimal medical treatment. During the follow-up, it was observed improvement of functional class, diastolic function, diastolic diameter of left ventricle, ejection fraction, mitral insufficiency, left atrial area, systolic lung pressure, synchrony parameters and myocardial function index with statistical significant difference in relation to the initial value (p<0.05). Survival at 44 months was 72%. Conclusion: the experience with heart resynchronization therapy and clinical and echocardiographic follow-up of the studied patients is similar to that found in other studies described in the literature

Embodying prostheses - how to let the body welcome assistive devices. Comment on "The embodiment of assistive devices-from wheelchair to exoskeleton" by M. Pazzaglia and M. Molinari

Science.gov (United States)

Longo, Matthew R.; Sadibolova, Renata; Tamè, Luigi

2016-03-01

A growing body of research has focused on the development of assistive devises to improve the recovery and ameliorate the quality of life of people suffering from spinal cord injuries (SCI). In their stimulating and timely paper, Pazzaglia and Molinari [1] review the significant progress made by biotechnology studies in providing increasing sophisticated assistive tools (e.g., prostheses and exoskeletons) that extend the functionality of patients' bodies. However, despite this extraordinary technological effort [2], it remains uncertain how these devices can be appropriately embedded into the mental representation of the body. Here, we wish to amplify the points raised by Pazzaglia and Molinari by discussing three challenges facing work on embodying prostheses raised by experimental research on body representation.

Internal vacuum-assisted closure device in the swine model of severe liver injury

Directory of Open Access Journals (Sweden)

Everett Christopher B

2012-12-01

Full Text Available Abstract Objectives The authors present a novel approach to nonresectional therapy in major hepatic trauma utilizing intraabdominal perihepatic vacuum assisted closure (VAC therapy in the porcine model of Grade V liver injury. Methods A Grade V injury was created in the right lobe of the liver in a healthy pig. A Pringle maneuver was applied (4.5 minutes total clamp time and a vacuum assisted closure device was placed over the injured lobe and connected to suction. The device consisted of a perforated plastic bag placed over the liver, followed by a 15 cm by 15cm VAC sponge covered with a nonperforated plastic bag. The abdomen was closed temporarily. Blood loss, cardiopulmonary parameters and bladder pressures were measured over a one-hour period. The device was then removed and the animal was euthanized. Results Feasibility of device placement was demonstrated by maintenance of adequate vacuum suction pressures and seal. VAC placement presented no major technical challenges. Successful control of ongoing liver hemorrhage was achieved with the VAC. Total blood loss was 625 ml (20ml/kg. This corresponds to class II hemorrhagic shock in humans and compares favorably to previously reported estimated blood losses with similar grade liver injuries in the swine model. No post-injury cardiopulmonary compromise or elevated abdominal compartment pressures were encountered, while hepatic parenchymal perfusion was maintained. Conclusion These data demonstrate the feasibility and utility of a perihepatic negative pressure device for the treatment of hemorrhage from severe liver injury in the porcine model.

Assistive devices alter gait patterns in Parkinson disease: advantages of the four-wheeled walker.

Science.gov (United States)

Kegelmeyer, Deb A; Parthasarathy, Sowmya; Kostyk, Sandra K; White, Susan E; Kloos, Anne D

2013-05-01

Gait abnormalities are a hallmark of Parkinson's disease (PD) and contribute to fall risk. Therapy and exercise are often encouraged to increase mobility and decrease falls. As disease symptoms progress, assistive devices are often prescribed. There are no guidelines for choosing appropriate ambulatory devices. This unique study systematically examined the impact of a broad range of assistive devices on gait measures during walking in both a straight path and around obstacles in individuals with PD. Quantitative gait measures, including velocity, stride length, percent swing and double support time, and coefficients of variation were assessed in 27 individuals with PD with or without one of six different devices including canes, standard and wheeled walkers (two, four or U-Step). Data were collected using the GAITRite and on a figure-of-eight course. All devices, with the exception of four-wheeled and U-Step walkers significantly decreased gait velocity. The four-wheeled walker resulted in less variability in gait measures and had less impact on spontaneous unassisted gait patterns. The U-Step walker exhibited the highest variability across all parameters followed by the two-wheeled and standard walkers. Higher variability has been correlated with increased falls. Though subjects performed better on a figure-of-eight course using either the four-wheeled or the U-Step walker, the four-wheeled walker resulted in the most consistent improvement in overall gait variables. Laser light use on a U-Step walker did not improve gait measures or safety in figure-of-eight compared to other devices. Of the devices tested, the four-wheeled-walker offered the most consistent advantages for improving mobility and safety. Copyright © 2012 Elsevier B.V. All rights reserved.

A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics.

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Bhavnani, Sanjeev P; Sola, Srikanth; Adams, David; Venkateshvaran, Ashwin; Dash, P K; Sengupta, Partho P

2018-04-01

This study sought to determine whether mobile health (mHealth) device assessments used as clinical decision support tools at the point-of-care can reduce the time to treatment and improve long-term outcomes among patients with rheumatic and structural heart diseases (SHD). Newly developed smartphone-connected mHealth devices represent promising methods to diagnose common diseases in resource-limited areas; however, the impact of technology-based care on long-term outcomes has not been rigorously evaluated. A total of 253 patients with SHD were randomized to an initial diagnostic assessment with wireless devices in mHealth clinics (n = 139) or to standard-care (n = 114) in India. mHealth clinics were equipped with point-of-care devices including pocket-echocardiography, smartphone-connected-electrocardiogram blood pressure and oxygen measurements, activity monitoring, and portable brain natriuretic peptide laboratory testing. All individuals underwent comprehensive transthoracic echocardiography to assess the severity of SHD. The primary endpoint was the time to referral for therapy with percutaneous valvuloplasty or surgical valve replacement. Secondary endpoints included the probability of a cardiovascular hospitalization and/or death over 1 year. An initial mHealth assessment was associated with a shorter time to referral for valvuloplasty and/or valve replacement (83 ± 79 days vs. 180 ± 101 days; p Mobile Health Device Assessments in Modern Structural Heart Disease Clinics; NCT02881398). Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Review of the International Society for Heart and Lung Transplantation Practice guidelines for management of heart failure in children.

Science.gov (United States)

Colan, Steven D

2015-08-01

imaging, and strain and strain rate were either novel or non-existent and have now moved into the main stream. Cardiac magnetic resonance imaging (MRI) had very limited availability, and since that time imaging and assessment of myocardial iron content, delayed gadolinium enhancement, and extracellular volume have moved into the mainstream. The only devices discussed in the International Society for Heart and Lung Transplantation guidelines were extracorporeal membrane oxygenators, pacemakers, and defibrillators. Since that time, ventricular assist devices have become mainstream. Despite the relative lack of randomised controlled trials in paediatric heart failure, advances continue to occur. These advances warrant implementation of an update and review process, something that is best done under the auspices of the national and international cardiology societies. A joint activity that includes the International Society for Heart and Lung Transplantation, American College of Cardiology/American Heart Association, the Association for European Paediatric and Congenital Cardiology (AEPC), European Society of Cardiology, Canadian Cardiovascular Society, and others will have more credibility than independent efforts by any of these organisations.

Accuracy of a Wrist-Worn Wearable Device for Monitoring Heart Rates in Hospital Inpatients: A Prospective Observational Study.

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Kroll, Ryan R; Boyd, J Gordon; Maslove, David M

2016-09-20

As the sensing capabilities of wearable devices improve, there is increasing interest in their application in medical settings. Capabilities such as heart rate monitoring may be useful in hospitalized patients as a means of enhancing routine monitoring or as part of an early warning system to detect clinical deterioration. To evaluate the accuracy of heart rate monitoring by a personal fitness tracker (PFT) among hospital inpatients. We conducted a prospective observational study of 50 stable patients in the intensive care unit who each completed 24 hours of heart rate monitoring using a wrist-worn PFT. Accuracy of heart rate recordings was compared with gold standard measurements derived from continuous electrocardiographic (cECG) monitoring. The accuracy of heart rates measured by pulse oximetry (Spo2.R) was also measured as a positive control. On a per-patient basis, PFT-derived heart rate values were slightly lower than those derived from cECG monitoring (average bias of -1.14 beats per minute [bpm], with limits of agreement of 24 bpm). By comparison, Spo2.R recordings produced more accurate values (average bias of +0.15 bpm, limits of agreement of 13 bpm, P<.001 as compared with PFT). Personal fitness tracker device performance was significantly better in patients in sinus rhythm than in those who were not (average bias -0.99 bpm vs -5.02 bpm, P=.02). Personal fitness tracker-derived heart rates were slightly lower than those derived from cECG monitoring in real-world testing and not as accurate as Spo2.R-derived heart rates. Performance was worse among patients who were not in sinus rhythm. Further clinical evaluation is indicated to see if PFTs can augment early warning systems in hospitals. ClinicalTrials.gov NCT02527408; https://clinicaltrials.gov/ct2/show/NCT02527408 (Archived by WebCite at  http://www.webcitation.org/6kOFez3on).

A novel approach in extracorporeal circulation: individual, integrated, and interactive heart-lung assist (I3-Assist).

Science.gov (United States)

Wagner, Georg; Schlanstein, Peter; Fiehe, Sandra; Kaufmann, Tim; Kopp, Rüdger; Bensberg, Ralf; Schmitz-Rode, Thomas; Steinseifer, Ulrich; Arens, Jutta

2014-04-01

Extracorporeal life support (ECLS) is a well-established technique for the treatment of different cardiac and pulmonary diseases, e.g., congenital heart disease and acute respiratory distress syndrome. Additionally, severely ill patients who cannot be weaned from the heart-lung machine directly after surgery have to be put on ECLS for further therapy. Although both systems include identical components, a seamless transition is not possible yet. The adaption of the circuit to the patients' size and demand is limited owing to the components available. The project I³-Assist aims at a novel concept for extracorporeal circulation. To better match the patient's therapeutic demand of support, an individual number of one-size oxygenators and heat exchangers will be combined. A seamless transition between cardiopulmonary bypass and ECLS will be possible as well as the exchange of components during therapy to enhance circuit maintenance throughout long-term support. Until today, a novel oxygenator and heat exchanger along with a simplified manufacturing protocol have been established. The first layouts of the unit to allow the spill- and bubble-free connection and disconnection of modules as well as improved cannulas and a rotational pump are investigated using computational fluid dynamics. Tests were performed according to current guidelines in vitro and in vivo. The test results show the feasibility and potential of the concept.

Development of a fixation device for robot assisted fracture reduction of femoral shaft fractures: a biomechanical study.

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Weber-Spickschen, T S; Oszwald, M; Westphal, R; Krettek, C; Wahl, F; Gosling, T

2010-01-01

Robot assisted fracture reduction of femoral shaft fractures provides precise alignment while reducing the amount of intraoperative imaging. The connection between the robot and the fracture fragment should allow conventional intramedullary nailing, be minimally invasive and provide interim fracture stability. In our study we tested three different reduction tools: a conventional External Fixator, a Reposition-Plate and a Three-Point-Device with two variations (a 40 degrees and a 90 degrees version). We measured relative movements between the tools and the bone fragments in all translation and rotation planes. The Three-Point-Device 90 degrees showed the smallest average relative displacement and was the only device able to withstand the maximum applied load of 70 Nm without failure of any bone fragment. The Three-Point-Device 90 degrees complies with all the stipulated requirements and is a suitable interface for robot assisted fracture reduction of femoral shaft fractures.

A Numerical Analysis of Phononic-Assisted Control of Ultrasound Waves in Acoustofluidic Device

DEFF Research Database (Denmark)

Moiseyenko, Rayisa; Bruus, Henrik

2015-01-01

and streaming has received much attention, since it relies solely on mechanical properties such as particle size and contrast in density and compressibility. We present a theoretical study of phononic-assisted control of ultrasound waves in acoustofluidic devices. We propose the use of phononic crystal...... diffractors, which can be introduced in acoustofluidic structures. These diffractors can be applied in the design of efficient resonant cavities, directional sound waves for new types of particle sorting methods, or acoustically controlled deterministic lateral displacement. The PnC-diffractor-based devices...... can be made configurable, by embedding the diffractors, all working at the same excitation frequency but with different resulting diffraction patterns, in exchangeable membranes on top of the device....

Development of mechanical circulatory support devices in China.

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Wang, Wei; Zhu, De-Ming; Ding, Wen-Xiang

2009-11-01

Myocardial dysfunction leading to low cardiac output syndrome is a common clinical pathophysiological state. Currently, the use of mechanical circulatory support (MCS) is an essential aspect of the treatment of patients with cardiac failure. Several groups in China are engaged in the design and development of MCS devices. These devices can be classified as pulsatile, rotary, and total artificial heart (TAH). There are two types of pulsatile pump, which are driven by air (pneumatic). One of these pumps, the Luo-Ye pump, has been used clinically for short-term support since 1998. The other is a push-plate left ventricular device, which has a variable rate mode. Various rotary devices are classified into axial and centrifugal pumps, depending on the impeller geometry. Most rotary pumps are based on the maglev principle, and some types have been used clinically. Others are still being studied in the laboratory or in animal experiments. Furthermore, certain types of total implantable pump, such as the UJS-III axial pump and the UJS-IV aortic valvo-pump, have been developed. Only one type of TAH has been developed in China. The main constituents of this artificial heart are two axial pumps, two reservoir tanks mimicking the right and left atria, flow meters, two pressure gauges, and a resistance adaptor. Although the development of mechanical assist devices in China is still in a nascent stage, a number of different types of MCS devices are currently being studied.

Loose-Lipped Mobile Device Intelligent Personal Assistants: A Discussion of Information Gleaned from Siri on Locked iOS Devices.

Science.gov (United States)

Horsman, Graeme

2018-04-23

The forensic analysis of mobile handsets is becoming a more prominent factor in many criminal investigations. Despite such devices frequently storing relevant evidential content to support an investigation, accessing this information is becoming an increasingly difficult task due to enhanced effective security features. Where access to a device's resident data is not possible via traditional mobile forensic methods, in some cases it may still be possible to extract user information via queries made to an installed intelligent personal assistant. This article presents an evaluation of the information which is retrievable from Apple's Siri when interacted with on a locked iOS device running iOS 11.2.5 (the latest at the time of testing). The testing of verbal commands designed to elicit a response from Siri demonstrate the ability to recover call log, SMS, Contacts, Apple Maps, Calendar, and device information which may support any further investigation. © 2018 American Academy of Forensic Sciences.

Design and prototyping of a wristband-type wireless photoplethysmographic device for heart rate variability signal analysis.

Science.gov (United States)

Ghamari, M; Soltanpur, C; Cabrera, S; Romero, R; Martinek, R; Nazeran, H

2016-08-01

Heart Rate Variability (HRV) signal analysis provides a quantitative marker of the Autonomic Nervous System (ANS) function. A wristband-type wireless photoplethysmographic (PPG) device was custom-designed to collect and analyze the arterial pulse in the wrist. The proposed device is comprised of an optical sensor to monitor arterial pulse, a signal conditioning unit to filter and amplify the analog PPG signal, a microcontroller to digitize the analog PPG signal, and a Bluetooth module to transfer the data to a smart device. This paper proposes a novel model to represent the PPG signal as the summation of two Gaussian functions. The paper concludes with a verification procedure for HRV signal analysis during sedentary activities.

Right ventricular dysfunction following continuous flow left ventriccular assist device placement in 51 patients: predicators and outcomes

Directory of Open Access Journals (Sweden)

Neragi-Miandoab Siyamek

2012-06-01

Full Text Available Abstract Background Right ventricular (RV dysfunction following implantation of a left ventricular assist device (LVAD is a serious condition and is associated with increased mortality. Methods The aim of the study is to investigate the significance of pre-existing RV dysfunction, tricuspid valve (TV insufficiency, and the severity of septal deviation following LVAD implantation on RV dysfunction, as well as the outcome and short-term complications in 51 patients from June 2006 to August 2010. Student t test was used to compare the data and estimate the p value. Results Mean age was 55.1 ± 13, with a male to female ratio of 3.25. The 30-day mortality was 13.7% (7/51 patients, and the overall mortality was 23.5% (12/51 patients. Meanwhile, 21 patients (21/51; 41.2% have undergone orthotopic heart transplantation. The mean time of support was 314.5±235 days with a median of 240 days at the time of closing this study. Echocardiographic evaluation of RV function pre- and post-implantation of an LVAD demonstrated septal deviation towards the left ventricle in immediate postoperative phase, which correlated with acute RV dysfunction (p = 0.002. Preoperative RV dysfunction was a significant predictor of postoperative right heart dysfunction following implantation of an LVAD (p = 0.001. Conclusion Preoperative RV dysfunction is a predictor of RV failure in LVAD patients. The adjustment of septal deviation through gradual increase of the LVAD flow can prevent the acute RV dysfunction following LVAD placement.

Noninvasive arterial blood pressure waveforms in patients with continuous-flow left ventricular assist devices

NARCIS (Netherlands)

Martina, Jerson R.; Westerhof, Berend E.; de Jonge, Nicolaas; van Goudoever, Jeroen; Westers, Paul; Chamuleau, Steven; van Dijk, Diederik; Rodermans, Ben F. M.; de Mol, Bas A. J. M.; Lahpor, Jaap R.

2014-01-01

Arterial blood pressure and echocardiography may provide useful physiological information regarding cardiac support in patients with continuous-flow left ventricular assist devices (cf-LVADs). We investigated the accuracy and characteristics of noninvasive blood pressure during cf-LVAD support.

Exertional Angina Due To Fused Aortic Bioprosthesis During Left Ventricular Assist Device Support: Two Cases and Review of the Literature.

Science.gov (United States)

Bonios, Michael J; Selzman, Craig H; Gilbert, Edward M; McKellar, Stephen H; Koliopoulou, Antigoni; Strege, Jennifer L; Nativi, Jose N; Fang, James C; Stehlik, Josef; Drakos, Stavros G

We present the case of two patients with idiopathic dilated cardiomyopathy and moderate aortic valve regurgitation that were treated with a bioprosthetic valve at the time of the left ventricular assist device (LVAD) implantation. A few months later, patients revealed partial recovery in the left ventricle systolic function. Both patients, during the LVAD turndown protocol, reported the onset of chest pain. The transthoracic echocardiography revealed the presence of a new transaortic pressure gradient. We confirmed the presence of a fused bioprosthetic valve by further performing a transesophageal echocardiogram and a left and right heart catheterization. Replacement of aortic valve at the time of an LVAD implantation constitutes a challenging case. Although a mechanical valve is contraindicated due to the increased thromboembolic risk, selecting a bioprosthetic valve increases the risk of valve leaflets fusion. The consequences of this phenomenon should be acknowledged in LVAD patients undergoing aortic valve replacement with a bioprosthetic, especially under the view of LVAD explantation for those revealing myocardial recovery under mechanical unloading.

Exercise guidelines for inpatients following ventricular assist device placement: a systematic review of the literature.

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Scheiderer, Rachel; Belden, Courtney; Schwab, Darla; Haney, Casey; Paz, Jaime

2013-06-01

For patients with end-stage heart failure awaiting transplantation, lack of donor organs has created an increased need for alternatives such as left ventricular assist device (LVAD) implantation. The purpose of this study is to determine safe and effective exercise parameters for physical therapy in the acute care setting. A systematic literature review was conducted according to PRISMA guidelines using Sackett's Levels of Evidence to rate the evidence. Multiple databases were searched with inclusion criteria of: available in English, inpatient care up to 6 months postoperatively, description of intervention type and exercise parameters. no defined exercise parameters, outpatient treatment, infection post VAD, or palliative or hospice care post VAD. Six studies out of 1,291 articles met inclusion criteria. Common exercise parameters used were the Borg Rating of Perceived Exertion scale 11-13 (6-20 scale) or > 4 (0-10 scale), Dyspnea scale > 2 (0-4 scale) and > 5 (0-10 scale), mean arterial pressure (MAP) 70-95 mmHg, and LVAD flow > 3L/min. Levels of evidence ranged from case controlled to expert opinion. Current evidence on inpatient exercise parameters for patient's status post LVAD implantation is not sufficient to suggest definitive guidelines; however, these exercise parameters provide a reference for patient care.

Bleeding with the artificial heart: Gastrointestinal hemorrhage in CF-LVAD patients.

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Gurvits, Grigoriy E; Fradkov, Elena

2017-06-14

Continuous-flow left ventricular assist devices (CF-LVADs) have significantly improved outcomes for patients with end-stage heart failure when used as a bridge to cardiac transplantation or, more recently, as destination therapy. However, its implantations carries a risk of complications including infection, device malfunction, arrhythmias, right ventricular failure, thromboembolic disease, postoperative and nonsurgical bleeding. A significant number of left ventricular assist devices (LVAD) recipients may experience recurrent gastrointestinal hemorrhage, mainly due to combination of antiplatelet and vitamin K antagonist therapy, activation of fibrinolytic pathway, acquired von Willebrand factor deficiency, and tendency to develop small intestinal angiodysplasias due to increased rotary speed of the pump. Gastrointestinal bleeding in LVAD patients remains a source of increased morbidity including the need for blood transfusions, extended hospital stays, multiple readmissions, and overall mortality. Management of gastrointestinal bleeding in LVAD patients involves multidisciplinary approach in stabilizing the patients, addressing risk factors and performing structured endoluminal evaluation with focus on upper gastrointestinal tract including jejunum to find and eradicate culprit lesion. Medical and procedural intervention is largely successful and universal bleeding cessation occurs in transplanted patients.

Biomechanical regulation of in vitro cardiogenesis for tissue-engineered heart repair.

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Zimmermann, Wolfram-Hubertus

2013-01-01

The heart is a continuously pumping organ with an average lifespan of eight decades. It develops from the onset of embryonic cardiogenesis under biomechanical load, performs optimally within a defined range of hemodynamic load, and fails if acutely or chronically overloaded. Unloading of the heart leads to defective cardiogenesis in utero, but can also lead to a desired therapeutic outcome (for example, in patients with heart failure under left ventricular assist device therapy). In light of the well-documented relevance of mechanical loading for cardiac physiology and pathology, it is plausible that tissue engineers have integrated mechanical stimulation regimens into protocols for heart muscle construction. To achieve optimal results, physiological principles of beat-to-beat myocardial loading and unloading should be simulated. In addition, heart muscle engineering, in particular if based on pluripotent stem cell-derived cardiomyocytes, may benefit from staggered tonic loading protocols to simulate viscoelastic properties of the prenatal and postnatal myocardial stroma. This review will provide an overview of heart muscle mechanics, summarize observations on the role of mechanical loading for heart development and postnatal performance, and discuss how physiological loading regimens can be exploited to advance myocardial tissue engineering towards a therapeutic application.

Pre- and post-operative risk factors associated with cerebrovascular accidents in patients supported by left ventricular assist device. -Single center's experience in japan-.

Science.gov (United States)

Nakajima, Ikutaro; Kato, Tomoko S; Komamura, Kazuo; Takahashi, Ayako; Oda, Noboru; Sasaoka, Taro; Asakura, Masanori; Hashimura, Kazuhiko; Kitakaze, Masafumi

2011-01-01

Cerebrovascular accident (CVA) is a major adverse event following left ventricular assist device (LVAD) surgery. This study investigates pre- and post-operative factors associated with CVA in this population. A total of 118 consecutive patients who underwent LVAD surgery at our institution between April 1994 and April 2009 were retrospectively reviewed. Clinical characteristics, hemodynamic data, and laboratory indexes associated with CVA after LVAD surgery were analyzed. In total, 57 (48.3%) patients developed CVA 133.5 ± 184.7 days after surgery. The combination of baseline heart disease, type of LVAD surgery, mean right atrial pressure (mRA), serum total bilirubin and total protein concentration, and right ventricular end-diastolic dimension (RVEDd) was associated with CVA at any time after LVAD surgery, with a discriminant probability of 718%. With regard to CVA development later than 3 months after surgery, the combination of mRA and RVEDd before surgery [odds ratio (OR), 1.24, 1.20; 95% confidential interval (CI), 1.07-1.42, 1.06-1.34; P = 0.004, P = 0.006, respectively], positive blood culture, and C-reactive protein after surgery (OR, 7.66, 2.19; 95%CI, 1.50-39.0, 1.47-3.25; P = 0.015, P < 0.0001, respectively) was associated with CVA with a discriminant probability of 85.9%. Patients' general condition including malnutrition, in addition to device selection, contributed to overall CVA development after surgery. In the chronic phase after surgery, pre-LVAD right heart failure and post-LVAD systemic infection were highly associated with CVA development.

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

Science.gov (United States)

Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

2007-01-01

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

Everolimus in Heart Transplantation: An Update

Directory of Open Access Journals (Sweden)

Stephan W. Hirt

2013-01-01

Full Text Available The evidence base relating to the use of everolimus in heart transplantation has expanded considerably in recent years, providing clinically relevant information regarding its use in clinical practice. Unless there are special considerations to take into account, all de novo heart transplant patients can be regarded as potential candidates for immunosuppression with everolimus and reduced-exposure calcineurin inhibitor therapy. Caution about the use of everolimus immediately after transplantation should be exercised in certain patients with the risk of severe proteinuria, with poor wound healing, or with uncontrolled severe hyperlipidemia. Initiation of everolimus in the early phase aftertransplant is not advisable in patients with severe pretransplant end-organ dysfunction or in patients on a left ventricular assist device beforetransplant who are at high risk of infection or of wound healing complications. The most frequent reason for introducing everolimus in maintenance heart transplant patients is to support minimization or withdrawal of calcineurin inhibitor therapy, for example, due to impaired renal function or malignancy. Due to its potential to inhibit the progression of cardiac allograft vasculopathy and to reduce cytomegalovirus infection, everolimus should be initiated as soon as possible after heart transplantation. Immediate and adequate reduction of CNI exposure is mandatory from the start of everolimus therapy.

Simulation of dilated heart failure with continuous flow circulatory support.

Directory of Open Access Journals (Sweden)

Yajuan Wang

Full Text Available Lumped parameter models have been employed for decades to simulate important hemodynamic couplings between a left ventricular assist device (LVAD and the native circulation. However, these studies seldom consider the pathological descending limb of the Frank-Starling response of the overloaded ventricle. This study introduces a dilated heart failure model featuring a unimodal end systolic pressure-volume relationship (ESPVR to address this critical shortcoming. The resulting hemodynamic response to mechanical circulatory support are illustrated through numerical simulations of a rotodynamic, continuous flow ventricular assist device (cfVAD coupled to systemic and pulmonary circulations with baroreflex control. The model further incorporated septal interaction to capture the influence of left ventricular (LV unloading on right ventricular function. Four heart failure conditions were simulated (LV and bi-ventricular failure with/without pulmonary hypertension in addition to normal baseline. Several metrics of LV function, including cardiac output and stroke work, exhibited a unimodal response whereby initial unloading improved function, and further unloading depleted preload reserve thereby reducing ventricular output. The concept of extremal loading was introduced to reflect the loading condition in which the intrinsic LV stroke work is maximized. Simulation of bi-ventricular failure with pulmonary hypertension revealed inadequacy of LV support alone. These simulations motivate the implementation of an extremum tracking feedback controller to potentially optimize ventricular recovery.

Laparoscopy-assisted percutaneous endoscopic gastrostomy using a "Funada-kit II" device.

Science.gov (United States)

Takahashi, Toshiaki; Miyano, Go; Shiyanagi, Satoko; Lane, Geoffrey J; Yamataka, Atsuyuki

2012-09-01

We aimed at assessing the effect of using a "Funada-kit II" device during laparoscopy-assisted percutaneous endoscopic gastrostomy (Lap-PEG), by reviewing 29 cases of Lap-PEG we performed from 2001 to 2011. We started using the "Funada-kit II" (CREATE MEDIC CO., Kanagawa, Japan) device with two parallel needles to puncture the stomach and assist suturing the anterior gastric wall to the anterior abdominal wall during Lap-PEG in 2011 (F-PEG). By introducing a loop through the lumen of one needle which allows placement of a suture introduced through the lumen of the other needle. Once repeated, the stomach can be pexied at two points, approximately 2 cm apart. We compared Lap-PEG (n = 23) with F-PEG (n = 6) where the mean ages and weights at surgery and sex ratios were similar. All cases were uneventful without intraoperative complications, although one postoperative wound infection occurred in a Lap-PEG case. There were no differences in the duration of analgesia, time taken to commence tube feeding, and return to full feeding. However, mean operating time was significantly shorter in F-PEG (28.1 min) versus Lap-PEG (46.1 min) p < 0.05. As per results F-PEG would appear to be as safe as Lap-PEG, but much quicker.

Older individuals' experiences during the assistive technology device service delivery process.

Science.gov (United States)

Gramstad, Astrid; Storli, Sissel Lisa; Hamran, Torunn

2014-07-01

Providing assistive technology devices to older individuals living in their ordinary homes is an important intervention to increase and sustain independence and to enable ageing at home. However, little is known about older individuals' experiences and needs in the assistive technology device (ATD) service delivery process. The purpose of this study was to investigate older individuals' experiences during the service delivery process of ATDs. Nine older individuals were interviewed three times each throughout the ATD service delivery process. The interviews were analysed within a hermeneutical phenomenological perspective. The results show that the service delivery process could be interpreted as an enigmatic journey and described using four themes: "hope and optimistic expectations", "managing after delivery or needing additional help", "having available help versus being abandoned", and "taking charge or putting up". The results emphasize the need for occupational therapists to maintain an individualized approach towards older clients throughout the service delivery process. The experiences of older individuals were diverse and related to expectations that were not necessarily articulated to the occupational therapist. The situation when the ATD is delivered to the client was highlighted by the clients as an important event with the potential to facilitate a successful service delivery process.

Energy costs of manual therapy: effects of plinth height and an assistive device.

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O'Connell, D G; Holmes, C F; Santos, J L; Jordan, E; Acosta, F

1994-01-01

The purpose of this investigation was to examine the metabolic and cardiopulmonary responses of an experienced therapist (8 years experience) performing manual therapy at standard (S) plinth height (31 in), elevated (E) plinth height (38 in), and standard (SMTH) and elevated (EMTH) plinth height wearing a manual therapy harness (MTH). The MTH, developed by one of the investigators (J.L.S.), is a vestlike device worn by the therapist, which, when attached to the patient, can be used to distract articular surfaces. The MTH allows the therapist more freedom of hand movement and use of body weight to help provide joint distraction. Inferior glide (Grade 3-Maitland) was provided to the lift hip of 12 individuals at a rate of 20 oscillations per minute for 4 minutes, continuously, so that steady-rate metabolic conditions could be established. Mean body mass and height for the 12 individuals was 70±10.5 kg and 174.5±13 cm, respectively. The therapist's heart rate returned to resting levels between each of the randomly assigned treatments. One subject was treated daily. The therapist (age 32) was chosen because of his clinical experience, similar height (172 em) and weight (73 kg) to the average adult American male, and excellent intra- and interday (5%≤ METs, 5%≤ HR) reproducibility. Metabolic equivalents (METs), heart rate (HR), and rate of perceived exertion (RPE) were measured and averaged for the last 2 minutes of each treatment condition. The therapist was unaware of day-to-day test results except for RPE. Mean METs were 3. 7,3.2,2.6, and 2.4 for S, E, SMTH, and EMTH, respectively. Mean HRs were .117, 110, 104, and 93 beats/min for S, E, SMTH, and EMTH, respectively. RPE was 11. 0,8.7, 7.9, and 7.3jorS, E, SMTH, and EMTH, respectively. Repeated-measures analysis of variance (Scheffé F-test) revealed that SMTH and EMTH METs were similar, and significantly different (p≤0.05) from Sand E. METs for E were significantly different and lower than for S. HRs were

The role of implantable cardioverter defibrillators in patients bridged to transplantation with a continuous-flow left ventricular assist device: A propensity score matched analysis.

Science.gov (United States)

Clerkin, Kevin J; Topkara, Veli K; Mancini, Donna M; Yuzefpolskaya, Melana; Demmer, Ryan T; Dizon, Jose M; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C; Garan, A Reshad

2017-06-01

Implantable cardioverter defibrillators (ICDs) provide a significant mortality benefit for appropriately selected patients with advanced heart failure. ICDs are associated with a mortality benefit when used in patients with a pulsatile left ventricular assist device (LVAD). It is unclear whether patients with a continuous-flow LVAD (CF-LVAD) derive the same benefit. We sought to determine if the presence of an ICD provided a mortality benefit during CF-LVAD support as a bridge to transplantation. Patients were identified in the United Network for Organ Sharing (UNOS) registry who underwent LVAD implantation as bridge to transplantation between May 2004 and April 2014, with follow-up through June 2014. Primary outcome was freedom from death while on CF-LVAD support with adjustment for complications requiring UNOS listing status upgrade. Secondary end-points included freedom from delisting while on CF-LVAD support and incidence of transplantation. The study cohort comprised 2,990 patients, and propensity score matching identified 1,012 patients with similar propensity scores. There was no difference in survival during device support between patients with and without an ICD (hazard ratio [HR] = 1.20; 95% confidence interval [CI], 0.66-2.17; p = 0.55). Adjusting for device complications requiring a UNOS listing status upgrade had minimal influence (HR = 1.11; 95% CI, 0.60-2.05; p = 0.74). There was no increased risk of delisting owing to being too sick for patients with an ICD (HR = 1.08; 95% CI, 0.63-1.86; p = 0.78). Likewise, the probability of transplantation was similar (HR = 1.05; 95% CI, 0.87-1.27; p = 0.62). Among patients bridged to transplantation with a CF-LVAD, the presence of an ICD did not reduce mortality. Copyright © 2017 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Improving Decision Making for Advanced Heart Failure Patients and Caregivers.

Science.gov (United States)

McIlvennan, Colleen K

2017-04-01

In this month's Magnet® Perspectives column, Colleen K. McIlvennan, DNP, ANP, lead nurse practitioner, Advanced Heart Failure and Transplantation at the University of Colorado, discusses her groundbreaking research encompassing patients' and caregivers' emotional, rational, and fundamental beliefs when considering a left ventricular assist device (LVAD). Results have led to the development of 2 innovative decision aids that are currently in use by LVAD programs across the United States and Canada. Dr McIlvennan's efforts led to a $2 million grant from the Patient-Centered Outcomes Research Institute, as well as national recognition from the American Heart Association and the Heart Failure Society of America. Last year, she received the 2016 National Magnet Nurse of the Year® Award in the Empirical Outcomes category. In addition to sharing her findings, Dr McIlvennan examines the value of performing research in a Magnet-recognized organization.

Physical interface dynamics alter how robotic exosuits augment human movement: implications for optimizing wearable assistive devices.

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Yandell, Matthew B; Quinlivan, Brendan T; Popov, Dmitry; Walsh, Conor; Zelik, Karl E

2017-05-18

Wearable assistive devices have demonstrated the potential to improve mobility outcomes for individuals with disabilities, and to augment healthy human performance; however, these benefits depend on how effectively power is transmitted from the device to the human user. Quantifying and understanding this power transmission is challenging due to complex human-device interface dynamics that occur as biological tissues and physical interface materials deform and displace under load, absorbing and returning power. Here we introduce a new methodology for quickly estimating interface power dynamics during movement tasks using common motion capture and force measurements, and then apply this method to quantify how a soft robotic ankle exosuit interacts with and transfers power to the human body during walking. We partition exosuit end-effector power (i.e., power output from the device) into power that augments ankle plantarflexion (termed augmentation power) vs. power that goes into deformation and motion of interface materials and underlying soft tissues (termed interface power). We provide empirical evidence of how human-exosuit interfaces absorb and return energy, reshaping exosuit-to-human power flow and resulting in three key consequences: (i) During exosuit loading (as applied forces increased), about 55% of exosuit end-effector power was absorbed into the interfaces. (ii) However, during subsequent exosuit unloading (as applied forces decreased) most of the absorbed interface power was returned viscoelastically. Consequently, the majority (about 75%) of exosuit end-effector work over each stride contributed to augmenting ankle plantarflexion. (iii) Ankle augmentation power (and work) was delayed relative to exosuit end-effector power, due to these interface energy absorption and return dynamics. Our findings elucidate the complexities of human-exosuit interface dynamics during transmission of power from assistive devices to the human body, and provide insight into

Airway Complications of Total Artificial Heart.

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Pathak, Vikas; Donovan, Colin; Malhotra, Rajiv

2017-02-01

The total artificial heart is the mechanical device which is used as a bridge to the heart transplant in patients with biventricular failure. Due to the mechanical nature of the device, patients receiving total artificial heart (TAH) require to be on anticoagulation therapy. Hemorrhage and coagulopathy are few of the known complications of TAH.

Beyond the VAD: Human Factors Engineering for Mechanically Assisted Circulation in the 21st Century.

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Throckmorton, Amy L; Patel-Raman, Sonna M; Fox, Carson S; Bass, Ellen J

2016-06-01

Thousands of ventricular assist devices (VADs) currently provide circulatory support to patients worldwide, and dozens of heart pump designs for adults and pediatric patients are under various stages of development in preparation for translation to clinical use. The successful bench-to-bedside development of a VAD involves a structured evaluation of possible system states, including human interaction with the device and auxiliary component usage in the hospital or home environment. In this study, we review the literature and present the current landscape of preclinical design and assessment, decision support tools and procedures, and patient-centered therapy. Gaps of knowledge are identified. The study findings support the need for more attention to user-centered design approaches for medical devices, such as mechanical circulatory assist systems, that specifically involve detailed qualitative and quantitative assessments of human-device interaction to mitigate risk and failure. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

The Eurotransplant High-Urgency Heart Transplantation Program: an option for patients in acute heart failure?

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Koch, A; Tochtermann, U; Remppis, A; Dengler, T J; Schnabel, P A; Hagl, S; Sack, F U

2006-09-01

The Eurotransplant High-Urgency (HU) Heart Transplantation Program allows urgent heart transplants to be carried out in rapidly deteriorating patients with acute-to-chronic heart failure on the elective waiting list. But do the results of HU heart transplantation justify performing primary heart transplantation in these critically ill patients and offer an acceptable outcome? Between 2000 and 2004, 64 heart transplantations (HTx) (32 elective and 32 HU-HTx) were performed in our department. After having been accepted in an auditing process based on HU criteria, intensive care patients in NYHA functional class IV (cardiac index 1.7 l/min/qm BS), in end-organ failure (creatinine 1.5 mg/dl), and with catecholamine dependence (dobutamine 8 microg/kg/min), are given priority with respect to organ allocation, and their data were compared to data from elective patients from the same period. HU requests were accepted in 97 % of cases. Two requests were not accepted, and both patients with contraindications for assist device implantation died within one week. The HU patients were 100 % in NYHA class IV, 93 % of the elective patients were in NYHA class III. Waiting time on the HU list was 13 days, and 7 of these patients died before HTx. Following heart transplantation, survival rates at 30 days and at one year of the HU group were 88 % and 85 % versus 94 % and 93 % in the elective group. This study shows that end-stage heart failure patients in the HU program can be transplanted primarily with good results if an organ is available in time. We are still in the position where the HU program only manages the organ shortage; there are still too many patients on the waiting list who die before receiving a donor organ.

Utilization of assistive devices for students with disabilities in the public schools

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Carolina Bastos Plotegher

2013-04-01

Full Text Available Introduction: Assistive technology is an area of expanding knowledge in Brazil. Its use in school can help students with disabilities in performing important tasks to participate in different activities. Objectives: to report the experience of using assistive devices in the academic achievement of students with disabilities included in the regular school system of the municipality of Sao Carlos, state of Sao Paulo. Method: it was developed from an extension project conducted in 2010. Thirteen students with various types of disabilities participated in the project. The interventions were based on the School Function Assessment with the teachers to know the students’ difficulties. The students were also observed performing school tasks. Results: Forty-seven adaptations were made: thickeners, rings for zippers, slants, communication boards, non-slip mats, among others. Besides the adjustments, orientation regarding use of the devices was provided for teachers and persons responsible for the students. Conclusion: we believe that the project benefited the students, because it produced higher academic achievement and provided better school conditions for their school inclusion. For the undergraduate students of Occupational Therapy, the project enabled the dealing with real issues of inclusion and school interventions, thus approaching theory to practice.

Catheter Ablation of Atrial Fibrillation in Patients with Hardware in the Heart - Septal Closure Devices, Mechanical Valves and More.

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Bartoletti, Stefano; Santangeli, Pasquale; DI Biase, Luigi; Natale, Andrea

2013-01-01

Patients with mechanical "hardware" in the heart, such as those with mechanical cardiac valves or atrial septal closure devices, represent a population at high risk of developing AF. Catheter ablation of AF in these subjects might represent a challenge, due to the perceived higher risk of complications associated with the presence of intracardiac mechanical devices. Accordingly, such patients were excluded or poorly represented in major trials proving the benefit of catheter ablation for the rhythm-control of AF. However, recent evidence supports the concept that catheter ablation procedures might be equally effective in these patients, without a significant increase in the risk of procedural complications. This review will summarize the current state-of-the-art on catheter ablation of AF in patients with mechanical "hardware" in the heart.

Echocardiographic evaluation of right ventricular stroke work index in advanced heart failure: a new index?

Science.gov (United States)

Frea, Simone; Bovolo, Virginia; Bergerone, Serena; D'Ascenzo, Fabrizio; Antolini, Marina; Capriolo, Michele; Canavosio, Federico Giovanni; Morello, Mara; Gaita, Fiorenzo

2012-12-01

Right ventricular (RV) function plays a pivotal role in advanced heart failure patients, especially for screening those who may benefit from left ventricular assist device (LVAD) implantation. We introduce RV contraction pressure index (RVCPI) as a new echo-Doppler parameter of RV function. The accuracy of RVCPI in detecting RV failure was compared with the criterion standard, the RV stroke work index (RVSWI) obtained through right heart catheterization in advanced heart failure patients referred for heart transplantation or LVAD implantation. Right heart catheterization and echo-Doppler were simultaneously performed in 94 consecutive patients referred to our center for advanced heart failure (ejection fraction (EF) 24 ± 8.8%, 40% NYHA functional class IV). RV stroke volume and invasive pulmonary pressures were used to obtain RVSWI. Simplified RVCPI (sRVCPI) was derived as TAPSE × (RV - right atrial pressure gradient). Close positive correlation between sRVCPI and RVSWI was found (r = 0.68; P rights reserved.

Accuracy of Heart Rate Watches: Implications for Weight Management.

Directory of Open Access Journals (Sweden)

Matthew P Wallen

Full Text Available Wrist-worn monitors claim to provide accurate measures of heart rate and energy expenditure. People wishing to lose weight use these devices to monitor energy balance, however the accuracy of these devices to measure such parameters has not been established.To determine the accuracy of four wrist-worn devices (Apple Watch, Fitbit Charge HR, Samsung Gear S and Mio Alpha to measure heart rate and energy expenditure at rest and during exercise.Twenty-two healthy volunteers (50% female; aged 24 ± 5.6 years completed ~1-hr protocols involving supine and seated rest, walking and running on a treadmill and cycling on an ergometer. Data from the devices collected during the protocol were compared with reference methods: electrocardiography (heart rate and indirect calorimetry (energy expenditure.None of the devices performed significantly better overall, however heart rate was consistently more accurate than energy expenditure across all four devices. Correlations between the devices and reference methods were moderate to strong for heart rate (0.67-0.95 [0.35 to 0.98] and weak to strong for energy expenditure (0.16-0.86 [-0.25 to 0.95]. All devices underestimated both outcomes compared to reference methods. The percentage error for heart rate was small across the devices (range: 1-9% but greater for energy expenditure (9-43%. Similarly, limits of agreement were considerably narrower for heart rate (ranging from -27.3 to 13.1 bpm than energy expenditure (ranging from -266.7 to 65.7 kcals across devices.These devices accurately measure heart rate. However, estimates of energy expenditure are poor and would have implications for people using these devices for weight loss.

Accuracy of Heart Rate Watches: Implications for Weight Management.

Science.gov (United States)

Wallen, Matthew P; Gomersall, Sjaan R; Keating, Shelley E; Wisløff, Ulrik; Coombes, Jeff S

2016-01-01

Wrist-worn monitors claim to provide accurate measures of heart rate and energy expenditure. People wishing to lose weight use these devices to monitor energy balance, however the accuracy of these devices to measure such parameters has not been established. To determine the accuracy of four wrist-worn devices (Apple Watch, Fitbit Charge HR, Samsung Gear S and Mio Alpha) to measure heart rate and energy expenditure at rest and during exercise. Twenty-two healthy volunteers (50% female; aged 24 ± 5.6 years) completed ~1-hr protocols involving supine and seated rest, walking and running on a treadmill and cycling on an ergometer. Data from the devices collected during the protocol were compared with reference methods: electrocardiography (heart rate) and indirect calorimetry (energy expenditure). None of the devices performed significantly better overall, however heart rate was consistently more accurate than energy expenditure across all four devices. Correlations between the devices and reference methods were moderate to strong for heart rate (0.67-0.95 [0.35 to 0.98]) and weak to strong for energy expenditure (0.16-0.86 [-0.25 to 0.95]). All devices underestimated both outcomes compared to reference methods. The percentage error for heart rate was small across the devices (range: 1-9%) but greater for energy expenditure (9-43%). Similarly, limits of agreement were considerably narrower for heart rate (ranging from -27.3 to 13.1 bpm) than energy expenditure (ranging from -266.7 to 65.7 kcals) across devices. These devices accurately measure heart rate. However, estimates of energy expenditure are poor and would have implications for people using these devices for weight loss.

Measurement of blood flow from an assist ventricle by computation of pneumatic driving parameters.

Science.gov (United States)

Qian, K X

1992-03-01

The measurement of blood flow from an assist ventricle is important but sometimes difficult in artificial heart experiments. Along with the development of a pneumatic cylinder-piston driver coupled with a ventricular assist device, a simplified method for measuring pump flow was established. From driving parameters such as the piston (or cylinder) displacement and air pressure, the pump flow could be calculated by the use of the equation of state for an ideal gas. The results of this method are broadly in agreement with electromagnetic and Doppler measurements.

Clinical effectiveness and cost-effectiveness of second- and third-generation left ventricular assist devices as either bridge to transplant or alternative to transplant for adults eligible for heart transplantation: systematic review and cost-effectiveness model.

Science.gov (United States)

Sutcliffe, P; Connock, M; Pulikottil-Jacob, R; Kandala, N-B; Suri, G; Gurung, T; Grove, A; Shyangdan, D; Briscoe, S; Maheswaran, H; Clarke, A

2013-11-01

Advanced heart failure (HF) is a debilitating condition for which heart transplant (HT) offers the best treatment option. However, the supply of donor hearts is diminishing and demand greatly exceeds supply. Ventricular assist devices (VADs) are surgically implanted pumps used as an alternative to transplant (ATT) or as a bridge to transplant (BTT) while a patient awaits a donor heart. Surgery and VADs are costly. For the NHS to allocate and deliver such services in a cost-effective way the relative costs and benefits of these alternative treatments need to be estimated. To investigate for patients aged ≥ 16 years with advanced HF eligible for HT: (1) the clinical effectiveness and cost-effectiveness of second- and third-generation VADs used as BTT compared with medical management (MM); and (2) the clinical effectiveness and cost-effectiveness of second- and third-generation VADs used as an ATT in comparison with their use as BTT therapy. Searches for clinical effectiveness studies covered years from 2003 to March 2012 and included the following data bases: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE), NHS Economic Evaluation Database (NHS EED), HTA databases [NHS Centre for Reviews and Dissemination (CRD)], Science Citation Index and Conference Proceedings (Web of Science), UK Clinical Research Network (UKCRN) Portfolio Database, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and National Library of Medicine (NLM) Gateway, Cochrane Central Register of Controlled Trials (CENTRAL), Current Controlled Trials and ClinicalTrials.gov. Reference lists of relevant articles were checked, and VAD manufacturers' websites interrogated. For economic analyses we made use of individual patient data (IPD) held in the UK Blood and Transplant Database (BTDB). Systematic reviews of evidence on clinical effectiveness and cost

Valvular Heart Disease in Heart Failure

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Giuseppe MC Rosano

2017-01-01

Full Text Available Structural valvular heart disease may be the cause of heart failure or may worsen the clinical status of patients with heart failure. Heart failure may also develop in patients treated with valve surgery. Patients with heart failure with valvular heart disease are at increased risk of events including sudden cardiac death. Before considering intervention (surgical or percutaneous all patients should receive appropriate medical and device therapy taking into account that vasodilators must be used with caution in patients with severe aortic stenosis. Numerous percutaneous and/or hybrid procedures have been introduced in the past few years and they are changing the management of valvular heart disease. In patients with heart failure and valvular heart disease, either primary or functional, the whole process of decision-making should be staged through a comprehensive evaluation of the risk– benefit ratio of different treatment strategies and should be made by a multidisciplinary ‘heart team’ with a particular expertise in valvular heart disease. The heart team should include heart failure cardiologists, cardiac surgeons/structural valve interventionists, imaging specialists, anaesthetists, geriatricians and intensive care specialists. This article will review recent developments and distill practical guidance in the management of this important heart failure co-morbidity.

The effect of device-based cardiac contractility modulation therapy on myocardial efficiency and oxidative metabolism in patients with heart failure

International Nuclear Information System (INIS)

Goliasch, Georg; Khorsand, Aliasghar; Sochor, Heinz; Schmidinger, Herwig; Graf, Senta; Schuetz, Matthias; Karanikas, Georgios; Khazen, Cesar; Wolzt, Michael

2012-01-01

Cardiac contractility modulation (CCM) is a device-based therapy that involves delivery of nonexcitatory electrical signals resulting in improved ventricular function and a reversal of maladaptive cardiac fetal gene programmes. Our aim was to evaluate whether acute application of CCM leads to an increase in myocardial oxygen consumption (MVO 2 ) in patients with chronic heart failure using 11 C-acetate positron emission tomography (PET). We prospectively enrolled 21 patients with severe heart failure. 11 C-acetate PET was performed before and after activation of the CCM device. In 12 patients an additional stress study with dobutamine was performed. Under resting conditions, the values of myocardial blood flow (MBF), MVO 2 and work metabolic index (WMI, reflecting myocardial efficiency) with the CCM device activated did not differ significantly from the values with the device deactivated. MBF was 0.81 ± 0.18 ml min -1 g -1 with the device off and 0.80 ± 0.15 ml min -1 g -1 with the device on (p = 0.818), MVO 2 was 6.81 ± 1.69 ml/min/100 g with the device off and 7.15 ± 1.62 ml/min/100 g with the device on (p = 0.241) and WMI was 4.94 ± 1.14 mmHg ml/m 2 with the device off and 5.21 ± 1.36 mmHg ml/m 2 with the device on (p = 0.344). Under dobutamine stress, the values of MBF, MVO 2 and WMI with the CCM device activated did not differ from the values with the device deactivated, but were significantly increased compared with the values obtained under resting conditions. These results indicate that CCM does not induce increased MVO 2 , even under stress conditions. (orig.)

The effect of device-based cardiac contractility modulation therapy on myocardial efficiency and oxidative metabolism in patients with heart failure

Energy Technology Data Exchange (ETDEWEB)

Goliasch, Georg; Khorsand, Aliasghar; Sochor, Heinz; Schmidinger, Herwig; Graf, Senta [Vienna General Hospital/Medical University of Vienna, Department of Cardiology, Vienna (Austria); Schuetz, Matthias; Karanikas, Georgios [Vienna General Hospital/Medical University of Vienna, Department of Nuclear Medicine, Vienna (Austria); Khazen, Cesar [Vienna General Hospital/ Medical University of Vienna, Department of Cardiothoracic Surgery, Vienna (Austria); Wolzt, Michael [Vienna General Hospital/Medical University of Vienna, Department of Cardiology, Vienna (Austria); Vienna General Hospital/ Medical University of Vienna, Department of Clinical Pharmacology, Vienna (Austria)

2012-03-15

Cardiac contractility modulation (CCM) is a device-based therapy that involves delivery of nonexcitatory electrical signals resulting in improved ventricular function and a reversal of maladaptive cardiac fetal gene programmes. Our aim was to evaluate whether acute application of CCM leads to an increase in myocardial oxygen consumption (MVO{sub 2}) in patients with chronic heart failure using {sup 11}C-acetate positron emission tomography (PET). We prospectively enrolled 21 patients with severe heart failure. {sup 11}C-acetate PET was performed before and after activation of the CCM device. In 12 patients an additional stress study with dobutamine was performed. Under resting conditions, the values of myocardial blood flow (MBF), MVO{sub 2} and work metabolic index (WMI, reflecting myocardial efficiency) with the CCM device activated did not differ significantly from the values with the device deactivated. MBF was 0.81 {+-} 0.18 ml min{sup -1} g{sup -1} with the device off and 0.80 {+-} 0.15 ml min{sup -1} g{sup -1} with the device on (p = 0.818), MVO{sub 2} was 6.81 {+-} 1.69 ml/min/100 g with the device off and 7.15 {+-} 1.62 ml/min/100 g with the device on (p = 0.241) and WMI was 4.94 {+-} 1.14 mmHg ml/m{sup 2} with the device off and 5.21 {+-} 1.36 mmHg ml/m{sup 2} with the device on (p = 0.344). Under dobutamine stress, the values of MBF, MVO{sub 2} and WMI with the CCM device activated did not differ from the values with the device deactivated, but were significantly increased compared with the values obtained under resting conditions. These results indicate that CCM does not induce increased MVO{sub 2}, even under stress conditions. (orig.)

MicroRNAs in Heart Failure, Cardiac Transplantation, and Myocardial Recovery: Biomarkers with Therapeutic Potential.

Science.gov (United States)

Shah, Palak; Bristow, Michael R; Port, J David

2017-12-01

Heart failure is increasing in prevalence with a lack of recently developed therapies that produce major beneficial effects on its associated mortality. MicroRNAs are small non-coding RNA molecules that regulate gene expression, are differentially regulated in heart failure, and are found in the circulation serving as a biomarker of heart failure. Data suggests that microRNAs may be used to detect allograft rejection in cardiac transplantation and may predict the degree of myocardial recovery in patients with a left ventricular assist device or treated with beta-blocker therapy. Given their role in regulating cellular function, microRNAs are an intriguing target for oligonucleotide therapeutics, designed to mimic or antagonize (antagomir) their biological effects. We review the current state of microRNAs as biomarkers of heart failure and associated conditions, the mechanisms by which microRNAs control cellular function, and how specific microRNAs may be targeted with novel therapeutics designed to treat heart failure.

Interacting with and via mobile devices and mobile robots in an assisted living setting

Directory of Open Access Journals (Sweden)

Maria Dagioglou

2015-05-01

Full Text Available Using robotic home assistants as a platform for remote health monitoring offers several advantages, but also presents considerable challenges related to both the technical immaturity of home robotics and to user acceptance issues. In this paper we explore tablets and similar mobile devices as the medium of communication between robots and their users, presenting relevant current and planned research in humanrobot interaction that can help the telehealth community circumvent technical shortcomings, improve user acceptance, and maximize the quality of the data collected by robotic home assistants.

Network-Assisted Distributed Fairness-Aware Interference Coordination for Device-to-Device Communication Underlaid Cellular Networks

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Francis Boabang

2017-01-01

Full Text Available Device-to-device (D2D communication underlaid cellular network is considered a key integration feature in future cellular network. However, without properly designed interference management, the interference from D2D transmission tends to degrade the performance of cellular users and D2D pairs. In this work, we proposed a network-assisted distributed interference mitigation scheme to address this issue. Specifically, the base station (BS acts as a control agent that coordinates the cross-tier interference from D2D transmission through a taxation scheme. The cotier interference is controlled by noncooperative game amongst D2D pairs. In general, the outcome of noncooperative game is inefficient due to the selfishness of each player. In our game formulation, reference user who is the victim of cotier interference is factored into the payoff function of each player to obtain fair and efficient outcome. The existence, uniqueness of the Nash Equilibrium (NE, and the convergence of the proposed algorithm are characterized using Variational Inequality theory. Finally, we provide simulation results to evaluate the efficiency of the proposed algorithm.

A microfluidic circulatory system integrated with capillary-assisted pressure sensors.

Science.gov (United States)

Chen, Yangfan; Chan, Ho Nam; Michael, Sean A; Shen, Yusheng; Chen, Yin; Tian, Qian; Huang, Lu; Wu, Hongkai

2017-02-14

The human circulatory system comprises a complex network of blood vessels interconnecting biologically relevant organs and a heart driving blood recirculation throughout this system. Recreating this system in vitro would act as a bridge between organ-on-a-chip and "body-on-a-chip" and advance the development of in vitro models. Here, we present a microfluidic circulatory system integrated with an on-chip pressure sensor to closely mimic human systemic circulation in vitro. A cardiac-like on-chip pumping system is incorporated in the device. It consists of four pumping units and passive check valves, which mimic the four heart chambers and heart valves, respectively. Each pumping unit is independently controlled with adjustable pressure and pump rate, enabling users to control the mimicked blood pressure and heartbeat rate within the device. A check valve is located downstream of each pumping unit to prevent backward leakage. Pulsatile and unidirectional flow can be generated to recirculate within the device by programming the four pumping units. We also report an on-chip capillary-assisted pressure sensor to monitor the pressure inside the device. One end of the capillary was placed in the measurement region, while the other end was sealed. Time-dependent pressure changes were measured by recording the movement of the liquid-gas interface in the capillary and calculating the pressure using the ideal gas law. The sensor covered the physiologically relevant blood pressure range found in humans (0-142.5 mmHg) and could respond to 0.2 s actuation time. With the aid of the sensor, the pressure inside the device could be adjusted to the desired range. As a proof of concept, human normal left ventricular and arterial pressure profiles were mimicked inside this device. Human umbilical vein endothelial cells (HUVECs) were cultured on chip and cells can respond to mechanical forces generated by arterial-like flow patterns.

A novel vibration assisted polishing device based on the flexural mechanism driven by the piezoelectric actuators

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Guilian Wang

2018-01-01

Full Text Available The vibration assisted polishing has widely application fields because of higher machining frequency and better polishing quality, especially the polishing with the non-resonant mode that is regarded as a kind of promising polishing method. This paper reports a novel vibration assisted polishing device, consisting of the flexible hinge mechanism driven by the piezoelectric actuators, which is suitable for polishing planes or curve surfaces with slow curvature. Firstly, the generation methods of vibration trajectory are investigated for the same frequency and different frequency signals’ inputs, respectively, and then the types of elliptic and Lissajous’s vibration trajectories are generated respectively. Secondly, a flexural mechanism consisting of the right circular flexible hinges and the leaf springs is developed to produce two-dimensional vibration trajectory. Statics and dynamics investigating of this flexible mechanism are finished in detail. The analytical models about input and output compliances of the flexural mechanism are established according to the matrix-based compliance modeling, and the dynamic model of the flexural mechanism based on the Euler-Lagrange equation is also presented. The finite element model of the flexural mechanism was established to carry out the numerical simulation in order to testify the rationality of device design. Finally, the polishing experiment is carried out to prove the effectiveness of the vibration device. The experimental results show that this novel vibration assisted polishing device developed in this study can remove more effectively the cutting marks left by last process and obviously reduce the workpiece surface roughness.

Association between cell-derived microparticles and adverse events in patients with nonpulsatile left ventricular assist devices.

Science.gov (United States)

Nascimbene, Angelo; Hernandez, Ruben; George, Joggy K; Parker, Anita; Bergeron, Angela L; Pradhan, Subhashree; Vijayan, K Vinod; Civitello, Andrew; Simpson, Leo; Nawrot, Maria; Lee, Vei-Vei; Mallidi, Hari R; Delgado, Reynolds M; Dong, Jing Fei; Frazier, O H

2014-05-01

Continuous-flow left ventricular assist devices (LVADs) expose blood cells to high shear stress, potentially resulting in the production of microparticles that express phosphatidylserine (PS+) and promote coagulation and inflammation. In this prospective study, we attempted to determine whether PS+ microparticle levels correlate with clinical outcomes in LVAD-supported patients. We enrolled 20 patients undergoing implantation of the HeartMate II LVAD (Thoratec Corp, Pleasanton, CA) and 10 healthy controls who provided reference values for the microparticle assays. Plasma was collected before LVAD implantation, at discharge, at the 3-month follow-up, and when an adverse clinical event occurred. We quantified PS+ microparticles in the plasma using flow cytometry. During the study period, 8 patients developed adverse clinical events: ventricular tachycardia storm in 1, non-ST-elevation myocardial infarction in 2, arterial thrombosis in 2, gastrointestinal bleeding in 2, and stroke in 3. Levels of PS+ microparticles were higher in patients at baseline than in healthy controls (2.11% ± 1.26% vs 0.69% ± 0.46%, p = 0.007). After LVAD implantation, patient PS+ microparticle levels increased to 2.39% ± 1.22% at discharge and then leveled to 1.97% ± 1.25% at the 3-month follow-up. Importantly, levels of PS+ microparticles were significantly higher in patients who developed an adverse event than in patients with no events (3.82% ± 1.17% vs 1.57% ± 0.59%, p microparticle levels may be associated with adverse clinical events. Thus, measuring PS+ microparticle levels in LVAD-supported patients may help identify patients at increased risk for adverse events. Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Sex and intimacy among patients with implantable left-ventricular assist devices.

Science.gov (United States)

Marcuccilli, Linda; Casida, Jesus Jessie; Peters, Rosalind M; Wright, Susan

2011-01-01

Left-ventricular assist devices (LVADs) sustain and improve the quality of life of people living with an advanced stage of heart failure. Past research focused on the development and advancement of LVAD technology, complications, and survival rates. Limited research addressed the psychosocial aspects of living with an LVAD, yet research related to sexual functioning and intimacy is lacking. The purpose of this study was to explore and describe sex and intimacy among adults living with an LVAD. We used an interpretive phenomenological study to explore the experiences of adults living with a long-term implantable LVAD, including the effect of the LVAD on their intimate and sexual functioning. Semistructured interviews were conducted with 7 men and 2 women, 31 to 70 years of age, who had lived with the LVAD at home for at least 3 months. Interviews were audiorecorded and transcribed. The wholistic and selective approach by van Manen (Researching Lived Experience: Human Science for an Action Sensitive Pedagogy. Albany, NY: SUNY Press; 1990) guided the analysis and interpretation of the transcribed interviews. Data were organized and coded into words and phrases using qualitative software. Three themes emerged from the data: (a) improved sexual relations with LVAD, (b) sexual adjustment, and (c) nonsexual intimacy. The themes identified were consistent with the concept of normalcy from the theory of self-care. Participants reported that as the LVAD improved their overall health, their sexual functioning also improved. Participants also reported an increased sense of connectedness and intimacy with their partners even in the absence of sexual intercourse. Participants discussed ways in which they continued to develop intimate relationships even in the presence of limitations in structural and functional integrity. The knowledge derived from this study can be used as a guide for healthcare providers in counseling LVAD recipients on psychosocial and sexual health essential

Modification of self-concept in patients with a left-ventricular assist device: an initial exploration.

Science.gov (United States)

Marcuccilli, Linda; Casida, Jesus; Peters, Rosalind M

2013-09-01

To explore how patients with left-ventricular assist devices (LVAD) meet the health-deviation requisite of modifying self-concept to accept this form of treatment and restore normalcy. LVAD are becoming a standard option to improve the quality of life for patients with advanced heart failure. Past research focused on technology issues and survival rates, but limited research has addressed the effect of LVADs on patients' perceptions of self. Orem's theory of self-care provides a framework to investigate how patients manage threats to self-concept to safely live with such a device. Hermeneutic phenomenology based on van Manen's method. Data were collected using semi-structured interviews. Data saturation was achieved with nine participants (seven men; two women), 31-70 years of age who lived with a LVAD at home for at least three months. Thematic analysis was ongoing, and final themes were consensually validated. Two themes constructed from the data were consistent with the requisite of modifying self-concept. First, Having a LVAD means living. Participants described they 'feel alive again', and they 'had the rest of [their] lives that they didn't have before'. The second theme: A desire to be 'normal' in public, arose from participants descriptions of how the LVAD brought unwanted attention to them and that their appearance was 'shocking' to others. Participants accepted the LVAD as necessary to live making it easier for them to modify their self-concept and accept the changes to their bodies and daily lives. Attaining a sense of normalcy was more difficult in public and required additional lifestyle modifications. Findings advance self-care knowledge in LVAD management and can heighten nurses' awareness about self-concept as a vital component for maintenance of health and well-being. © 2013 Blackwell Publishing Ltd.

Avaliação do desempenho hemodinâmico do dispositivo de assistência ventricular InCor como substituto do coração esquerdo Analysis of the hemodynamic performance of the InCor ventricular assist device as a substitute for the left heart

Directory of Open Access Journals (Sweden)

Anderson BENÍCIO

1999-07-01

dispositivo foi melhor quanto maior o nível de vácuo no sistema de drenagem e com a utilização de cânula ventricular.BACKGROUND: The mechanical circulatory assistance is a therapeutic option in cases of cardiogenic shock refractory to the pharmacological treatment, and is frequently used as a bridge for heart transplantation. OBJECTIVE: To evaluate the action of the Ventricular Assist Device (VAD developed by the Bioengineering Division of the Instituto do Coração, implanted as a substitute of the left heart. PATIENTS AND METHODS: Ten Girolando calves with medium weight of 73 kg were studied. The VAD-InCor implant was accomplished with the drainage cannula positioned in the left atrium (LA or in the apex of the left ventricle and the replacement cannula implanted in the descending thoracic aorta. The pressures of the right and left heart, cardiac output and the flow of VAD were determined before and after the pharmacological induction of myocardial failure, at different levels of vacuum of the drainage system. RESULTS: Values of the flow of VAD with the drainage in LA were of 2.2 ± 0.5 l/min without vacuum, of 3.7 ± 0.4 with vacuum of 10 mmHg, of 4.3 ± 0.4 with vacuum of 20 mmHg and of 4.8 ± 0.6 with vacuum of 30 mmHg. The values of the pressure of LA were: 11.7 ± 6; 9.8 ± 5.3; 8.5 ± 4.4 and 5.6 ± 3.3 mmHg under the same conditions, respectively. With the ventricular cannula, the VAD flow was 4.2 ± 0.6 without vacuum and of 4.4 ± 0.7 with vacuum of 10 mmHg, with of LA pressure of 11.1 ± 2 and 10.3 ± 3.5 mmHg in the two conditions. Those results were observed in similar hemodynamic conditions, with the VAD flow responsible for a greater percentile of the total cardiac output according to the level of vacuum. That percentile was of 86 ± 13% with the atrial cannula and vacuum of 30 mmHg and of 97 ± 3% with the ventricular drainage and vacuum of 10 mmHg. CONCLUSIONS: The VAD-InCor demonstrated its effectiveness as a substitute of the left heart. The

Prototype of a mechanical assistance device for the wrists' flexion-extension movement

International Nuclear Information System (INIS)

Politti, Julio C; Puglisi, Lisandro J; Farfan, Fernando D

2007-01-01

Using CMU actuators, a Prototype of Mechanical Assistance Device for the Wrist's Flexion Movement (PMA) was developed and probed in a mechanical model, in order to be implemented in a future as a dynamic powered orthosis or as a rehabilitation assistant instrument. Two Mayor Actuators conformed by three CMU actuators arranged in a series configuration, allows to an artificial hand to be placed in four predefined positions: 0 0 , 20 0 , 40 0 and 60 0 . The synchronism and control of the actuators is achieved with the Programmable Control Module (PCM). It is capable to drive up to six CMU actuators, and possess two different modes of execution: a Manual mode and an Exercise mode. In the Manual Mode, the position of the hand responds directly to the commands of the keyboard of the front panel, and in the Exercise mode, the hand realizes a repetitive and programmed movement. The prototype was tested in 100 positions in the Manual Mode and for 225 works cycles in the Exercise Mode. The relative repetition error was less than 5% for both test. This prototype only consumes 4,15W, which makes it possible to be powered by small rechargeable batteries, allowing its use as a portable device

Minimally Invasive Cochlear Implantation Assisted by Bi-planar Device: An Exploratory Feasibility Study in vitro

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Jia Ke

2016-01-01

Conclusions: This exploratory study demonstrated the safety of the newly developed image-guided minimally invasive cochlear implantation assisted by the bi-planar device and established the operational procedures. Further, more in vitro experiments are needed to improve the system operation and its safety.

Does reduced movement restrictions and use of assistive devices affect rehabilitation outcome after total hip replacement?

DEFF Research Database (Denmark)

Mikkelsen, Lone Ramer; Petersen, Annemette Krintel; Søballe, Kjeld

2014-01-01

slower recovery in patient-reported function after reduction in movement restrictions and use of assistive devices, but the difference was eliminated after 6 weeks. Reduced movement restrictions did not affect the other patient-reported outcomes and led to earlier return to work. CLINICAL REHABILITATION......). This group was compared to patients included the following 3 months with less restricted hip movement and use of assistive devices according to individual needs (unrestricted group). Questionnaires on function, pain, quality of life (HOOS), anxiety (HADS), working status and patient satisfaction were.......004). Return to work 6 weeks after THR for the unrestricted group compared to restricted group was: 53% versus 32% (P=0.045). No significant differences between groups in pain, symptoms, quality of life, anxiety/depression, hip dislocations and patient satisfaction. CONCLUSION: This study showed slightly...

Vapor cycle energy system for implantable circulatory assist devices. Annual progress report Jul 1974--Jun 1975

International Nuclear Information System (INIS)

Hagen, K.G.

1975-06-01

The report describes the development status of a heart assist system driven by a nuclear fueled, electronically controlled vapor cycle engine termed the tidal regenerator engine (TRE). The TRE pressurization (typically from 5-160 psia) is controlled by a torque motor coupled to a displacer. The electrical power for the sensor, electronic logic and actuator is provided by a thermoelectric module interposed between the engine superheater and boiler. The TRE is direct coupled to an assist blood pump which also acts as a blood-cooled heat exchanger, pressure-volume transformer and sensor for the electronic logic. Engine efficiencies in excess of 14% have been demonstrated. Efficiency values as high as 13% have been achieved to date

Electromagnetic modelling of current flow in the heart from TASER devices and the risk of cardiac dysrhythmias

Energy Technology Data Exchange (ETDEWEB)

Holden, S J [Defence Science and Technology Laboratory, Porton Down, Salisbury, Wiltshire SP4 0JQ (United Kingdom); Sheridan, R D [Defence Science and Technology Laboratory, Porton Down, Salisbury, Wiltshire SP4 0JQ (United Kingdom); Coffey, T J [Mathshop Ltd, Porton Down Science Park, Salisbury, Wiltshire SP4 0JQ (United Kingdom); Scaramuzza, R A [Flomerics Ltd, Electromagnetic Division, TLM House, Percy Street, Nottingham NG16 3EP (United Kingdom); Diamantopoulos, P [Bio-Medical Modelling Unit, School of Engineering, University of Sussex, Falmer, Sussex BN1 9QT (United Kingdom)

2007-12-21

Increasing use by law enforcement agencies of the M26 and X26 TASER electrical incapacitation devices has raised concerns about the arrhythmogenic potential of these weapons. Using a numerical phantom constructed from medical images of the human body in which the material properties of the tissues are represented, computational electromagnetic modelling has been used to predict the currents arising at the heart following injection of M26 and X26 waveforms at the anterior surface of the chest (with one TASER 'barb' directly overlying the ventricles). The modelling indicated that the peak absolute current densities at the ventricles were 0.66 and 0.11 mA mm{sup -2} for the M26 and X26 waveforms, respectively. When applied during the vulnerable period to the ventricular epicardial surface of guinea-pig isolated hearts, the M26 and X26 waveforms induced ectopic beats, but only at current densities greater than 60-fold those predicted by the modelling. When applied to the ventricles in trains designed to mimic the discharge patterns of the TASER devices, neither waveform induced ventricular fibrillation at peak currents >70-fold (for the M26 waveform) and >240-fold (for the X26) higher than the modelled current densities. This study provides evidence for a lack of arrhythmogenic action of the M26 and X26 TASER devices.

Design of a Code-Maker Translator Assistive Input Device with a Contest Fuzzy Recognition Algorithm for the Severely Disabled

Directory of Open Access Journals (Sweden)

Chung-Min Wu

2015-01-01

Full Text Available This study developed an assistive system for the severe physical disabilities, named “code-maker translator assistive input device” which utilizes a contest fuzzy recognition algorithm and Morse codes encoding to provide the keyboard and mouse functions for users to access a standard personal computer, smartphone, and tablet PC. This assistive input device has seven features that are small size, easy installing, modular design, simple maintenance, functionality, very flexible input interface selection, and scalability of system functions, when this device combined with the computer applications software or APP programs. The users with severe physical disabilities can use this device to operate the various functions of computer, smartphone, and tablet PCs, such as sending e-mail, Internet browsing, playing games, and controlling home appliances. A patient with a brain artery malformation participated in this study. The analysis result showed that the subject could make himself familiar with operating of the long/short tone of Morse code in one month. In the future, we hope this system can help more people in need.

An assistance device to help people with trunk impairment maintain posture.

Science.gov (United States)

Ogura, Tomoka; Itami, Taku; Yano, Ken'ichi; Mori, Ichidai; Kameda, Kazuhiro

2017-07-01

People with trunk impairment cannot lean forward because of the dysfunction of the trunk resulting from events such as cervical cord injury (CCI). It is therefore difficult for such people to work at a table because they may easily fall from their wheelchair, and it is also hard for them to return to their original position. This limits the activities of daily living (ADLs) of people with trunk impairment. These problems can be solved to some extent with equipment such as a wheelchair belt or a spinal orthosis that can help the person to maintain his or her posture. However, people cannot move freely with this equipment. Furthermore, if this equipment is used for a long time, there is a risk of physical pain and skin issues. In this study, we developed a device that assists the trunk of people with trunk impairment when they lean forward. This device supports people with trunk impairment so that they may take their meals at the table and prevents them from falling over their wheelchair without hindering their daily performance when they are sitting normally. The effectiveness of our proposed device was verified by experiments involving having a meal, operating a wheelchair, and colliding with a curb. Our device can help people with trunk impairment by improving their ADLs and quality of life (QOL).

The effect of garden designs on mood and heart output in older adults residing in an assisted living facility.

Science.gov (United States)

Goto, Seiko; Park, Bum-Jin; Tsunetsugu, Yuko; Herrup, Karl; Miyazaki, Yoshifumi

2013-01-01

The objective of this study is to trace short-term changes in mood and heart function in elderly individuals in response to exposure to different landscaped spaces. Nineteen elderly but cognitively intact residents of an assisted living facility participated in the study. They were exposed to three landscaped spaces: a Japanese style garden, an herb garden, and a simple landscaped area planted with a single tree. To assess the effect of different landscaped spaces on older adults, individuals were monitored for mood and cardiac function in response to short exposures to spaces. Mood state was assessed using Profile of Mood States (POMS) before and after viewing the spaces. Cardiac output was assessed using a portable electrocardiograph monitor before and during the viewing. We found that the structured gardens evoked greater responses in all outcome measures. Scores on the POMS improved after observation of the two organized gardens compared to responses to the simple landscaped space with a single tree. During the observation period, heart rate was significantly lower in the Japanese garden than in the other environments, and sympathetic function was significantly lower as well. We conclude that exposure to organized gardens can affect both the mood and cardiac physiology of elderly individuals. Our data further suggest that these effects can differ depending on the types of landscape to which an individual is exposed. Elderly, Japanese garden, herb garden, heart rate, mood, healing environmentPreferred Citation: Goto, S., Park, B-J., Tsunetsugu, Y., Herrup, K., & Miyazaki, Y. (2013). The effect of garden designs on mood and heart output in older adults residing in an assisted living facility. Health Environments Research & Design Journal 6(2), pp 27-42.

Diffractive optical devices produced by light-assisted trapping of nanoparticles.

Science.gov (United States)

Muñoz-Martínez, J F; Jubera, M; Matarrubia, J; García-Cabañes, A; Agulló-López, F; Carrascosa, M

2016-01-15

One- and two-dimensional diffractive optical devices have been fabricated by light-assisted trapping and patterning of nanoparticles. The method is based on the dielectrophoretic forces appearing in the vicinity of a photovoltaic crystal, such as Fe:LiNbO3, during or after illumination. By illumination with the appropriate light distribution, the nanoparticles are organized along patterns designed at will. One- and two-dimensional diffractive components have been achieved on X- and Z-cut Fe:LiNbO3 crystals, with their polar axes parallel and perpendicular to the crystal surface, respectively. Diffraction gratings with periods down to around a few micrometers have been produced using metal (Al, Ag) nanoparticles with radii in the range of 70-100 nm. Moreover, several 2D devices, such as Fresnel zone plates, have been also produced showing the potential of the method. The diffractive particle patterns remain stable when light is removed. A method to transfer the diffractive patterns to other nonphotovoltaic substrates, such as silica glass, has been also reported.

Vapor cycle energy system for implantable circulatory assist devices. Final summary May--Oct 1976

International Nuclear Information System (INIS)

Watelet, R.P.; Ruggles, A.E.; Hagen, K.G.

1977-03-01

The report describes the development status of a heart assist system driven by a nuclear-fueled, electronically controlled vapor cycle engine termed the tidal regenerator engine (TRE). The TRE pressurization is controlled by a torque motor coupled to a displacer. The electrical power for the sensor, electronic logic and actuator is provided by thermoelectric modules interposed between the engine superheater and boiler. The TRE is direct-coupled to an assist blood pump which also acts as a blood-cooled heat exchanger, pressure-volume trasformer and sensor for the electronic logic. Engine cycle efficiency in excess of 14% has been demonstrated routinely. Overall system efficiency on 33 watts of over 9% has been demonstrated (implied 13% engine cycle efficiency). A binary version of this engine in the annular configuration is now being tested. The preliminary tests demonstrated 10% cycle efficiency on the first buildup which ran well and started easily

An Implantable Intravascular Pressure Sensor for a Ventricular Assist Device

Directory of Open Access Journals (Sweden)

Luigi Brancato

2016-08-01

Full Text Available The aim of this study is to investigate the intravascular application of a micro-electro-mechanical system (MEMS pressure sensor to directly measure the hemodynamic characteristics of a ventricular assist device (VAD. A bio- and hemo-compatible packaging strategy is implemented, based on a ceramic thick film process. A commercial sub-millimeter piezoresistive sensor is attached to an alumina substrate, and a double coating of polydimethylsiloxane (PDMS and parylene-C is applied. The final size of the packaged device is 2.6 mm by 3.6 mm by 1.8 mm. A prototype electronic circuit for conditioning and read-out of the pressure signal is developed, satisfying the VAD-specific requirements of low power consumption (less than 14.5 mW in continuous mode and small form factor. The packaged sensor has been submitted to extensive in vitro tests. The device displayed a temperature-independent sensitivity (12 μ V/V/mmHg and good in vitro stability when exposed to the continuous flow of saline solution (less than 0.05 mmHg/day drift after 50 h. During in vivo validation, the transducer has been successfully used to record the arterial pressure waveform of a female sheep. A small, intravascular sensor to continuously register the blood pressure at the inflow and the outflow of a VAD is developed and successfully validated in vivo.

An Examination of the Impact of an Assistive Technology Device on the Quality of Adult/Young Child Interactions

Science.gov (United States)

Plunkett, Diane M.

2013-01-01

The purpose of this study was to gain greater understanding of the potential benefits of assistive technology (AT) devices on young children's social development. Specifically, changes to the quality of the adult/young child social interactions as a function of the child's access to and use of his/her personal AT device was examined. Using a…

Ultrasound functional imaging in an ex vivo beating porcine heart platform

Science.gov (United States)

Petterson, Niels J.; Fixsen, Louis S.; Rutten, Marcel C. M.; Pijls, Nico H. J.; van de Vosse, Frans N.; Lopata, Richard G. P.

2017-12-01

In recent years, novel ultrasound functional imaging (UFI) techniques have been introduced to assess cardiac function by measuring, e.g. cardiac output (CO) and/or myocardial strain. Verification and reproducibility assessment in a realistic setting remain major issues. Simulations and phantoms are often unrealistic, whereas in vivo measurements often lack crucial hemodynamic parameters or ground truth data, or suffer from the large physiological and clinical variation between patients when attempting clinical validation. Controlled validation in certain pathologies is cumbersome and often requires the use of lab animals. In this study, an isolated beating pig heart setup was adapted and used for performance assessment of UFI techniques such as volume assessment and ultrasound strain imaging. The potential of performing verification and reproducibility studies was demonstrated. For proof-of-principle, validation of UFI in pathological hearts was examined. Ex vivo porcine hearts (n  =  6, slaughterhouse waste) were resuscitated and attached to a mock circulatory system. Radio frequency ultrasound data of the left ventricle were acquired in five short axis views and one long axis view. Based on these slices, the CO was measured, where verification was performed using flow sensor measurements in the aorta. Strain imaging was performed providing radial, circumferential and longitudinal strain to assess reproducibility and inter-subject variability under steady conditions. Finally, strains in healthy hearts were compared to a heart with an implanted left ventricular assist device, simulating a failing, supported heart. Good agreement between ultrasound and flow sensor based CO measurements was found. Strains were highly reproducible (intraclass correlation coefficients  >0.8). Differences were found due to biological variation and condition of the hearts. Strain magnitude and patterns in the assisted heart were available for different pump action, revealing

The Syncardia™ total artificial heart: in vivo, in vitro, and computational modeling studies

Science.gov (United States)

Slepian, Marvin J.; Alemu, Yared; Soares, João Silva; Smith, Richard G.; Einav, Shmuel; Bluestein, Danny

2014-01-01

The SynCardia™ total artificial heart (TAH) is the only FDA-approved TAH in the world. The SynCardia™ TAH is a pneumatically driven, pulsatile system capable of flows of >9 L/min. The TAH is indicated for use as a bridge to transplantation (BTT) in patients at imminent risk of death from non-reversible bi-ventricular failure. In the Pivotal US approval trial the TAH achieved a BTT rate of >79%. Recently a multi-center, post-market approval study similarly demonstrated a comparable BTT rate. A major milestone was recently achieved for the TAH, with over 1100 TAHs having been implanted to date, with the bulk of implantation occurring at an ever increasing rate in the past few years. The TAH is most commonly utilized to save the lives of patients dying from end-stage bi-ventricular heart failure associated with ischemic or non-ischemic dilated cardiomyopathy. Beyond progressive chronic heart failure, the TAH has demonstrated great efficacy in supporting patients with acute irreversible heart failure associated with massive acute myocardial infarction. In recent years several diverse clinical scenarios have also proven to be well served by the TAH including severe heart failure associated with advanced congenital heart disease. failed or burned-out transplants, infiltrative and restrictive cardiomyopathies and failed ventricular assist devices. Looking to the future a major unmet need remains in providing total heart support for children and small adults. As such, the present TAH design must be scaled to fit the smaller patient, while providing equivalent, if not superior flow characteristics, shear profiles and overall device thrombogenicity. To aid in the development of a new “pediatric,” TAH an engineering methodology known as “Device Thrombogenicity Emulation (DTE)”, that we have recently developed and described, is being employed. Recently, to further our engineering understanding of the TAH, as steps towards next generation designs we have: (1

Combined heart-kidney transplantation after total artificial heart insertion.

Science.gov (United States)

Ruzza, A; Czer, L S C; Ihnken, K A; Sasevich, M; Trento, A; Ramzy, D; Esmailian, F; Moriguchi, J; Kobashigawa, J; Arabia, F

2015-01-01

We present the first single-center report of 2 consecutive cases of combined heart and kidney transplantation after insertion of a total artificial heart (TAH). Both patients had advanced heart failure and developed dialysis-dependent renal failure after implantation of the TAH. The 2 patients underwent successful heart and kidney transplantation, with restoration of normal heart and kidney function. On the basis of this limited experience, we consider TAH a safe and feasible option for bridging carefully selected patients with heart and kidney failure to combined heart and kidney transplantation. Recent FDA approval of the Freedom driver may allow outpatient management at substantial cost savings. The TAH, by virtue of its capability of providing pulsatile flow at 6 to 10 L/min, may be the mechanical circulatory support device most likely to recover patients with marginal renal function and advanced heart failure. Copyright © 2015 Elsevier Inc. All rights reserved.

Demikhov's "Mechanical Heart": The Circumstances Surrounding Creation of the World's First Implantable Total Artificial Heart in 1937.

Science.gov (United States)

Glyantsev, Sergey P; Tchantchaleishvili, Vakhtang; Bockeria, Leo A

2016-01-01

The world's first implantable total artificial heart was designed by Vladimir Demikhov as a fourth year biology student in Voronezh, Soviet Union, in 1937. As a prototype of his device, Demikhov must have used an apparatus for extracorporeal blood circulation invented by Sergei Bryukhonenko of Moscow. The device was the size of a dog's native heart and consisted of two diaphragm pumps brought into motion by an electric motor. A dog with an implanted device lived for 2.5 hours. In addition to having the prototype, the preconditions for Demikhov's artificial heart creation were his manual dexterity, expertise in animal physiology, and his mechanistic worldview.

Simulation of Ventricular, Cavo-Pulmonary, and Biventricular Ventricular Assist Devices in Failing Fontan.

Science.gov (United States)

Di Molfetta, Arianna; Amodeo, Antonio; Fresiello, Libera; Trivella, Maria Giovanna; Iacobelli, Roberta; Pilati, Mara; Ferrari, Gianfranco

2015-07-01

Considering the lack of donors, ventricular assist devices (VADs) could be an alternative to heart transplantation for failing Fontan patients, in spite of the lack of experience and the complex anatomy and physiopathology of these patients. Considering the high number of variables that play an important role such as type of Fontan failure, type of VAD connection, and setting (right VAD [RVAD], left VAD [LVAD], or biventricular VAD [BIVAD]), a numerical model could be useful to support clinical decisions. The aim of this article is to develop and test a lumped parameter model of the cardiovascular system simulating and comparing the VAD effects on failing Fontan. Hemodynamic and echocardiographic data of 10 Fontan patients were used to simulate the baseline patients' condition using a dedicated lumped parameter model. Starting from the simulated baseline and for each patient, a systolic dysfunction, a diastolic dysfunction, and an increment of the pulmonary vascular resistance were simulated. Then, for each patient and for each pathology, the RVAD, LVAD, and BIVAD implantations were simulated. The model can reproduce patients' baseline well. In the case of systolic dysfunction, the LVAD unloads the single ventricle and increases the cardiac output (CO) (35%) and the arterial systemic pressure (Pas) (25%). With RVAD, a decrement of inferior vena cava pressure (Pvci) (39%) was observed with 34% increment of CO, but an increment of the single ventricle external work (SVEW). With the BIVAD, an increment of Pas (29%) and CO (37%) was observed. In the case of diastolic dysfunction, the LVAD increases CO (42%) and the RVAD decreases the Pvci, while both increase the SVEW. In the case of pulmonary vascular resistance increment, the highest CO (50%) and Pas (28%) increment is obtained with an RVAD with the highest decrement of Pvci (53%) and an increment of the SVEW but with the lowest VAD power consumption. The use of numerical models could be helpful in this innovative

Development of a power-assisted lifting device for construction and periodic inspection

International Nuclear Information System (INIS)

Hayatsu, M.; Yamada, M.; Takasu, H.; Tagawa, Y.; Kajiwara, K.

2001-01-01

This study focuses on the control system design and control performance of a power-assisted lifting device. The device consists of several electric chain-blocks, each controlled by force sensors and a CPU. The mechanism is as follows: (1) Force sensors detect any chain tension changes (by human force), (2) The CPU calculates the required output, (3) Electric chain-blocks move the object in the intended direction. The feature of this device is that it does not require any information related to the suspension points of the electric chain-blocks. The controller was designed using the H method, which considers disturbances and aims to provide robust stability under the operation conditions of construction verified through experiments using a 700 kg steel dummy mass (control object) suspended by four electric chain-blocks. In the experiments, the controller, which was designed using the H method, was compared to the PI controller method, and the effectiveness of the H controller was proven. A control object could be moved, translated, and rotated by human force (of less than 10 kg). Positioning performance errors were suppressed to less than 0.5 mm, and operation time was reduced by about 50%. This device will improve working efficiency and rationalize lifting operations in nuclear power plants. (author)

Development of a power-assisted lifting device for construction and periodic inspection

Energy Technology Data Exchange (ETDEWEB)

Hayatsu, M.; Yamada, M.; Takasu, H. [Hitachi Plant Engineering and Construction, Chiba-ken (Japan); Tagawa, Y. [Tokyo Univ. of Agriculture and Technology (Japan); Kajiwara, K. [National Research Institute for Earth Science and Disaster Prevention, Tokyo (Japan)

2001-07-01

This study focuses on the control system design and control performance of a power-assisted lifting device. The device consists of several electric chain-blocks, each controlled by force sensors and a CPU. The mechanism is as follows: (1) Force sensors detect any chain tension changes (by human force), (2) The CPU calculates the required output, (3) Electric chain-blocks move the object in the intended direction. The feature of this device is that it does not require any information related to the suspension points of the electric chain-blocks. The controller was designed using the H method, which considers disturbances and aims to provide robust stability under the operation conditions of construction verified through experiments using a 700 kg steel dummy mass (control object) suspended by four electric chain-blocks. In the experiments, the controller, which was designed using the H method, was compared to the PI controller method, and the effectiveness of the H controller was proven. A control object could be moved, translated, and rotated by human force (of less than 10 kg). Positioning performance errors were suppressed to less than 0.5 mm, and operation time was reduced by about 50%. This device will improve working efficiency and rationalize lifting operations in nuclear power plants. (author)

RELATION OF FETAL BLOOD-GASES AND DATA FROM COMPUTER-ASSISTED ANALYSIS OF FETAL HEART-RATE PATTERNS IN SMALL FOR GESTATION FETUSES

NARCIS (Netherlands)

RIBBERT, LSM; SNIJDERS, RJM; NICOLAIDES, KH; VISSER, GHA

Fetal heart rate (FHR) monitoring and computer-assisted analysis were performed immediately before cordocentesis in 25 severely small-for-gestational age fetuses. There were significant associations between FHR variation and both umbilical vein blood Po2 (r = 0.66) and pH (r = 0.69). However, the

Investigating the Role of Interventricular Interdependence in Development of Right Heart Dysfunction During LVAD Support: A Patient-Specific Methods-Based Approach

Directory of Open Access Journals (Sweden)

Kevin L. Sack

2018-05-01

Full Text Available Predictive computation models offer the potential to uncover the mechanisms of treatments whose actions cannot be easily determined by experimental or imaging techniques. This is particularly relevant for investigating left ventricular mechanical assistance, a therapy for end-stage heart failure, which is increasingly used as more than just a bridge-to-transplant therapy. The high incidence of right ventricular failure following left ventricular assistance reflects an undesired consequence of treatment, which has been hypothesized to be related to the mechanical interdependence between the two ventricles. To investigate the implication of this interdependence specifically in the setting of left ventricular assistance device (LVAD support, we introduce a patient-specific finite-element model of dilated chronic heart failure. The model geometry and material parameters were calibrated using patient-specific clinical data, producing a mechanical surrogate of the failing in vivo heart that models its dynamic strain and stress throughout the cardiac cycle. The model of the heart was coupled to lumped-parameter circulatory systems to simulate realistic ventricular loading conditions. Finally, the impact of ventricular assistance was investigated by incorporating a pump with pressure-flow characteristics of an LVAD (HeartMate II™ operating between 8 and 12 k RPM in parallel to the left ventricle. This allowed us to investigate the mechanical impact of acute left ventricular assistance at multiple operating-speeds on right ventricular mechanics and septal wall motion. Our findings show that left ventricular assistance reduces myofiber stress in the left ventricle and, to a lesser extent, right ventricle free wall, while increasing leftward septal-shift with increased operating-speeds. These effects were achieved with secondary, potentially negative effects on the interventricular septum which showed that support from LVADs, introduces unnatural bending

Artificial heart for humanoid robot

Science.gov (United States)

Potnuru, Akshay; Wu, Lianjun; Tadesse, Yonas

2014-03-01

A soft robotic device inspired by the pumping action of a biological heart is presented in this study. Developing artificial heart to a humanoid robot enables us to make a better biomedical device for ultimate use in humans. As technology continues to become more advanced, the methods in which we implement high performance and biomimetic artificial organs is getting nearer each day. In this paper, we present the design and development of a soft artificial heart that can be used in a humanoid robot and simulate the functions of a human heart using shape memory alloy technology. The robotic heart is designed to pump a blood-like fluid to parts of the robot such as the face to simulate someone blushing or when someone is angry by the use of elastomeric substrates and certain features for the transport of fluids.

Identification of tasks performed by stroke patients using a mobility assistive device

DEFF Research Database (Denmark)

Hester, Todd; Sherrill, Delsey M; Hamel, Mathieu

2006-01-01

of these devices. In this study, we propose the use of wearable sensors to identify tasks performed by stroke patients with a mobility assistive device. Subjects performed ten tasks with a three-axis accelerometer attached to their ankle and a neural network was trained to identify the task being performed...... tasks associated with the use of a cane. Therefore, we envision that the methodology presented in this paper could be used to evaluate the use of a cane in the context of the task being performed........ Results from 15 stroke patients indicated that these motor tasks can be reliably identified with a median sensitivity of 90 % at a median specificity of 95%. These results indicate that it is possible to use a single module with a three-axis accelerometer attached to the ankle to reliably identify motor...

Grasp Assist Device with Shared Tendon Actuator Assembly

Science.gov (United States)

Ihrke, Chris A. (Inventor); Bergelin, Bryan J. (Inventor); Bridgwater, Lyndon (Inventor)

2015-01-01

A grasp assist device includes a glove with first and second tendon-driven fingers, a tendon, and a sleeve with a shared tendon actuator assembly. Tendon ends are connected to the respective first and second fingers. The actuator assembly includes a drive assembly having a drive axis and a tendon hook. The tendon hook, which defines an arcuate surface slot, is linearly translatable along the drive axis via the drive assembly, e.g., a servo motor thereof. The flexible tendon is routed through the surface slot such that the surface slot divides the flexible tendon into two portions each terminating in a respective one of the first and second ends. The drive assembly may include a ball screw and nut. An end cap of the actuator assembly may define two channels through which the respective tendon portions pass. The servo motor may be positioned off-axis with respect to the drive axis.

Memory-assisted measurement-device-independent quantum key distribution

Science.gov (United States)

Panayi, Christiana; Razavi, Mohsen; Ma, Xiongfeng; Lütkenhaus, Norbert

2014-04-01

A protocol with the potential of beating the existing distance records for conventional quantum key distribution (QKD) systems is proposed. It borrows ideas from quantum repeaters by using memories in the middle of the link, and that of measurement-device-independent QKD, which only requires optical source equipment at the user's end. For certain memories with short access times, our scheme allows a higher repetition rate than that of quantum repeaters with single-mode memories, thereby requiring lower coherence times. By accounting for various sources of nonideality, such as memory decoherence, dark counts, misalignment errors, and background noise, as well as timing issues with memories, we develop a mathematical framework within which we can compare QKD systems with and without memories. In particular, we show that with the state-of-the-art technology for quantum memories, it is potentially possible to devise memory-assisted QKD systems that, at certain distances of practical interest, outperform current QKD implementations.

Memory-assisted measurement-device-independent quantum key distribution

International Nuclear Information System (INIS)

Panayi, Christiana; Razavi, Mohsen; Ma, Xiongfeng; Lütkenhaus, Norbert

2014-01-01

A protocol with the potential of beating the existing distance records for conventional quantum key distribution (QKD) systems is proposed. It borrows ideas from quantum repeaters by using memories in the middle of the link, and that of measurement-device-independent QKD, which only requires optical source equipment at the user's end. For certain memories with short access times, our scheme allows a higher repetition rate than that of quantum repeaters with single-mode memories, thereby requiring lower coherence times. By accounting for various sources of nonideality, such as memory decoherence, dark counts, misalignment errors, and background noise, as well as timing issues with memories, we develop a mathematical framework within which we can compare QKD systems with and without memories. In particular, we show that with the state-of-the-art technology for quantum memories, it is potentially possible to devise memory-assisted QKD systems that, at certain distances of practical interest, outperform current QKD implementations. (paper)

New Innovations in Circulatory Support With Ventricular Assist Device and Extracorporeal Membrane Oxygenation Therapy.

Science.gov (United States)

Sladen, Robert N

2017-04-01

The past decade has seen an exponential increase in the application and development of durable long-term as well as nondurable short-term mechanical circulatory support for cardiogenic shock and acute or chronic heart failure. Support has evolved from bridge-to-transplant to destination therapy, bridge to rescue, bridge to decision making, and bridge to a bridge. Notable trends include device miniaturization, minimally invasive and/or percutaneous insertion, and efforts to superimpose pulsatility on continuous flow. We can certainly anticipate that innovation will accelerate in the months and years to come. However, despite-or perhaps because of-the enhanced equipment now available, mechanical circulatory support is an expensive, complex, resource-intensive modality. It requires considerable expertise that should preferably be centralized to highly specialized centers. Formidable challenges remain: systemic inflammatory response syndromes and vasoplegia after device insertion; postoperative sepsis; optimal anticoagulation regimens to prevent device-induced thrombosis and cerebral thromboembolism; wound site, intracranial, and gastrointestinal bleeding; multisystem injury and failure; patient dissatisfaction (even when providers consider the procedure a "success"); and ethical decision making in conditions of futility.

21 CFR 884.6130 - Assisted reproduction microtools.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Assisted reproduction microtools. 884.6130 Section... (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Assisted Reproduction Devices § 884.6130 Assisted reproduction microtools. (a) Identification. Assisted reproduction microtools are pipettes or...

21 CFR 884.6200 - Assisted reproduction laser system.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Assisted reproduction laser system. 884.6200... (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL DEVICES Assisted Reproduction Devices § 884.6200 Assisted reproduction laser system. (a) Identification. The assisted reproduction laser system is a device...

Heart bypass surgery - minimally invasive

Science.gov (United States)

... MIDCAB; Robot-assisted coronary artery bypass; RACAB; Keyhole heart surgery; CAD - MIDCAB; Coronary artery disease - MIDCAB ... To perform this surgery: The heart surgeon will make a 3- to 5-inch (8 to 13 centimeters) surgical cut in the left part of your chest ...

New Monitoring Technology to Objectively Assess Adherence to Prescribed Footwear and Assistive Devices During Ambulatory Activity

NARCIS (Netherlands)

Bus, Sicco A.; Waaijman, Roelof; Nollet, Frans

2012-01-01

Bus SA, Waaijman R, Nollet F. New monitoring technology to objectively assess adherence to prescribed footwear and assistive devices during ambulatory activity. Arch Phys Med Rehabil 2012;93:2075-9. Objective: To assess the validity and feasibility of a new temperature-based adherence monitor to

Flow visualization of a monoleaflet and bileaflet mechanical heart valve in a pneumatic ventricular assist device using a PIV system.

Science.gov (United States)

Lee, Hwansung; Tatsumi, Eisuke; Taenaka, Yoshiyuki

2010-01-01

Our group is developing a new type of pulsatile pneumatic ventricular assist device (PVAD) that uses the Medtronic Hall tilting disc valve (M-H valve). Although tilting disc valves have good washout effect inside the blood pump, they are no longer in common clinical use and may be difficult to obtain in the future. To investigate the stability of the Sorin Bicarbon valve (S-B valve) in our PVAD, we constructed a model pump made of an acrylic resin with the same configuration as our PVAD and attempted to compare the flow visualization upstream and downstream of the outlet position valve between the M-H valve and the S-B valve using a particle image velocimetry (PIV) method. The outlet S-B valve had faster closure than the M-H valve. The maximum flow velocity was greater than with the M-H valve. The maximum Reynolds shear stress (RSS) of the M-H valve reached 150 N/m(2) and that of the S-B valve reached 300 N/m(2) upstream during the end-systolic and early-diastolic phases. In both valves, the maximum RSS upstream of the valve was higher than downstream of the valve because of the regurgitation flow during valve closure. In addition, the maximum viscous shear stress reached above 2 N/m(2), which occupied only about 1%-1.5% of the maximum RSS.

Intraoperative Hemodynamic and Echocardiographic Measurements Associated With Severe Right Ventricular Failure After Left Ventricular Assist Device Implantation.

Science.gov (United States)

Gudejko, Michael D; Gebhardt, Brian R; Zahedi, Farhad; Jain, Ankit; Breeze, Janis L; Lawrence, Matthew R; Shernan, Stanton K; Kapur, Navin K; Kiernan, Michael S; Couper, Greg; Cobey, Frederick C

2018-06-05

Severe right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation increases morbidity and mortality. We investigated the association between intraoperative right heart hemodynamic data, echocardiographic parameters, and severe versus nonsevere RVF. A review of LVAD patients between March 2013 and March 2016 was performed. Severe RVF was defined by the need for a right ventricular mechanical support device, inotropic, and/or inhaled pulmonary vasodilator requirements for >14 days. From a chart review, the right ventricular failure risk score was calculated and right heart hemodynamic data were collected. Pulmonary artery pulsatility index (PAPi) [(pulmonary artery systolic pressure - pulmonary artery diastolic pressure)/central venous pressure (CVP)] was calculated for 2 periods: (1) 30 minutes before cardiopulmonary bypass (CPB) and (2) after chest closure. Echocardiographic data were recorded pre-CPB and post-CPB by a blinded reviewer. Univariate logistic regression models were used to examine the performance of hemodynamic and echocardiographic metrics. A total of 110 LVAD patients were identified. Twenty-five did not meet criteria for RVF. Of the remaining 85 patients, 28 (33%) met criteria for severe RVF. Hemodynamic factors associated with severe RVF included: higher CVP values after chest closure (18 ± 9 vs 13 ± 5 mm Hg; P = .0008) in addition to lower PAPi pre-CPB (1.2 ± 0.6 vs 1.7 ± 1.0; P = .04) and after chest closure (0.9 ± 0.5 vs 1.5 ± 0.8; P = .0008). Post-CPB echocardiographic findings associated with severe RVF included: larger right atrial diameter major axis (5.4 ± 0.9 vs 4.9 ± 1.0 cm; P = .03), larger right ventricle end-systolic area (22.6 ± 8.4 vs 18.5 ± 7.9 cm; P = .03), lower fractional area of change (20.2 ± 10.8 vs 25.9 ± 12.6; P = .04), and lower tricuspid annular plane systolic excursion (0.9 ± 0.2 vs 1.1 ± 0.3 cm; P = .008). Right ventricular failure risk score was not a significant predictor of

Outcomes of pediatric patients supported with continuous-flow ventricular assist devices: A report from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS).

Science.gov (United States)

Rossano, Joseph W; Lorts, Angela; VanderPluym, Christina J; Jeewa, Aamir; Guleserian, Kristine J; Bleiweis, Mark S; Reinhartz, Olaf; Blume, Elizabeth D; Rosenthal, David N; Naftel, David C; Cantor, Ryan S; Kirklin, James K

2016-05-01

Continuous-flow (CF) ventricular assist devices (VADs) have largely replaced pulsatile-flow VADs in adult patients. However, there are few data on CF VADs among pediatric patients. In this study we aimed to describe the overall use, patients' characteristics and outcomes of CF VADs in this population. The Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS) is a national registry for U.S. Food and Drug Adminstration (FDA)-approved VADs in patients <19 years of age. Patients undergoing placement of durable CF VADs between September 2012 and June 2015 were included and outcomes were compared with those of adults from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). CF VADs were implanted in 109 patients at 35 hospitals. The median age at implantation was 15 years (2.8 to 18.9 years) and median weight was 62 kg (range 16 to 141 kg). The underlying disease was cardiomyopathy in 89 (82%) patients. The INTERMACS level at time of implant was Level 1 in 20 (19%), Level 2 in 64 (61%) and Levels 3 to 7 in 21 (20%) patients. Most were implanted as LVADs (n = 102, 94%). Median duration of support was 2.3 months (range <1 day to 28 months). Serious adverse event rates were low, including neurologic dysfunction (early event rate 4.1 per 100 patient-months with 2 late events). Competing outcomes analysis at 6 months post-implant indicated 61% transplanted, 31% alive with device in place and 8% death before transplant. These outcomes compared favorably with the 3,894 adults supported with CF VADs as a bridge to transplant. CF VADs are commonly utilized in older children and adolescents, with excellent survival rates. Further study is needed to understand impact of patient and device characteristics on outcomes in pediatric patients. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

AbioCor totally implantable artificial heart. How will it impact hospitals?

Science.gov (United States)

2002-09-01

Although heart transplantation remains the most effective treatment for severe heart failure, there are far fewer donor hearts available than there are patients who could benefit from them. One approach to addressing this shortfall is the total artificial heart, or TAH. To date, however, no TAH design has been able to achieve one of the ultimate goals of heart replacement: to allow a patient to live a reasonably normal life without being connected to external machinery. A new design, the AbioCor TAH developed by Abiomed Inc., may make this goal achievable. Thanks to a power system that transfers energy through the skin without the aid of wires, the AbioCor--currently undergoing clinical trials in the United States--allows the patient to be completely mobile. The lack of transcutaneous wires also eliminates the primary source of the infections that have plagued TAH patients in the past. Though it is not without drawbacks, the AbioCor could represent a crucial advance in TAH technology. In this Technology Overview, we describe the operation of the AbioCor and discuss its likely impact on hospitals if it is approved for marketing in the United States. We also discuss a related cardiac-support technology: ventricular assist devices (VADs), which may also be used for permanent cardiac support someday.

Extracorporeal Life Support Bridge to Ventricular Assist Device: The Double Bridge Strategy.

Science.gov (United States)

Marasco, Silvana F; Lo, Casey; Murphy, Deirdre; Summerhayes, Robyn; Quayle, Margaret; Zimmet, Adam; Bailey, Michael

2016-01-01

In patients requiring left ventricular assist device (LVAD) support, it can be difficult to ascertain suitability for long-term mechanical support with LVAD and eventual transplantation. LVAD implantation in a shocked patient is associated with increased morbidity and mortality. Interest is growing in the utilization of extracorporeal life support (ECLS) as a bridge-to-bridge support for these critically unwell patients. Here, we reviewed our experience with ECLS double bridging. We hypothesized that ECLS double bridging would stabilize end-organ dysfunction and reduce ventricular assist device (VAD) implant perioperative mortality. We conducted a retrospective review of prospectively collected data for 58 consecutive patients implanted with a continuous-flow LVAD between January 2010 and December 2013 at The Alfred Hospital, Melbourne, Victoria, Australia. Twenty-three patients required ECLS support pre-LVAD while 35 patients underwent LVAD implantation without an ECLS bridge. Preoperative morbidity in the ECLS bridge group was reflected by increased postoperative intensive care duration, blood loss, blood product use, and postoperative renal failure, but without negative impact upon survival when compared with the no ECLS group. ECLS stabilization improved end-organ function pre-VAD implant with significant improvements in hepatic and renal dysfunction. This series demonstrates that the use of ECLS bridge to VAD stabilizes end-organ dysfunction and reduces VAD implant perioperative mortality from that traditionally reported in these "crash and burn" patients. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

"The Heart Game"

DEFF Research Database (Denmark)

Dithmer, Marcus; Rasmussen, Jack Ord; Grönvall, Erik

2016-01-01

Objective: The aim of this article is to describe the development and testing of a prototype application (“The Heart Game”) using gamification principles to assist heart patients in their telerehabilitation process in the Teledialog project. Materials and Methods: A prototype game was developed via...... (interviews, participant observations, focus group interviews, and workshop) was used. Interviews with three healthcare professionals and 10 patients were carried out over a period of 2 weeks in order to evaluate the use of the prototype. Results: The heart patients reported the application to be a useful...... activities. Conclusions: “The Heart Game” concept presents a new way to motivate heart patients by using technology as a social and active approach to telerehabilitation. The findings show the potential of using gamification for heart patients as part of a telerehabilitation program. The evaluation indicated...

Use of Inotropic Agents in Treatment of Systolic Heart Failure

Directory of Open Access Journals (Sweden)

Sohaib Tariq

2015-12-01

Full Text Available The most common use of inotropes is among hospitalized patients with acute decompensated heart failure, with reduced left ventricular ejection fraction and with signs of end-organ dysfunction in the setting of a low cardiac output. Inotropes can be used in patients with severe systolic heart failure awaiting heart transplant to maintain hemodynamic stability or as a bridge to decision. In cases where patients are unable to be weaned off inotropes, these agents can be used until a definite or escalated supportive therapy is planned, which can include coronary revascularization or mechanical circulatory support (intra-aortic balloon pump, extracorporeal membrane oxygenation, impella, left ventricular assist device, etc.. Use of inotropic drugs is associated with risks and adverse events. This review will discuss the use of the inotropes digoxin, dopamine, dobutamine, norepinephrine, milrinone, levosimendan, and omecamtiv mecarbil. Long-term inotropic therapy should be offered in selected patients. A detailed conversation with the patient and family shall be held, including a discussion on the risks and benefits of use of inotropes. Chronic heart failure patients awaiting heart transplants are candidates for intravenous inotropic support until the donor heart becomes available. This helps to maintain hemodynamic stability and keep the fluid status and pulmonary pressures optimized prior to the surgery. On the other hand, in patients with severe heart failure who are not candidates for advanced heart failure therapies, such as transplant and mechanical circulatory support, inotropic agents can be used for palliative therapy. Inotropes can help reduce frequency of hospitalizations and improve symptoms in these patients.

Use of Inotropic Agents in Treatment of Systolic Heart Failure.

Science.gov (United States)

Tariq, Sohaib; Aronow, Wilbert S

2015-12-04

The most common use of inotropes is among hospitalized patients with acute decompensated heart failure, with reduced left ventricular ejection fraction and with signs of end-organ dysfunction in the setting of a low cardiac output. Inotropes can be used in patients with severe systolic heart failure awaiting heart transplant to maintain hemodynamic stability or as a bridge to decision. In cases where patients are unable to be weaned off inotropes, these agents can be used until a definite or escalated supportive therapy is planned, which can include coronary revascularization or mechanical circulatory support (intra-aortic balloon pump, extracorporeal membrane oxygenation, impella, left ventricular assist device, etc.). Use of inotropic drugs is associated with risks and adverse events. This review will discuss the use of the inotropes digoxin, dopamine, dobutamine, norepinephrine, milrinone, levosimendan, and omecamtiv mecarbil. Long-term inotropic therapy should be offered in selected patients. A detailed conversation with the patient and family shall be held, including a discussion on the risks and benefits of use of inotropes. Chronic heart failure patients awaiting heart transplants are candidates for intravenous inotropic support until the donor heart becomes available. This helps to maintain hemodynamic stability and keep the fluid status and pulmonary pressures optimized prior to the surgery. On the other hand, in patients with severe heart failure who are not candidates for advanced heart failure therapies, such as transplant and mechanical circulatory support, inotropic agents can be used for palliative therapy. Inotropes can help reduce frequency of hospitalizations and improve symptoms in these patients.

Left ventricular remodeling in the post-infarction heart: a review of cellular, molecular mechanisms, and therapeutic modalities.

Science.gov (United States)

Gajarsa, Jason J; Kloner, Robert A

2011-01-01

As more patients survive myocardial infarctions, the incidence of heart failure increases. After an infarction, the human heart undergoes a series of structural changes, which are governed by cellular and molecular mechanisms in a pathological metamorphosis termed "remodeling." This review will discuss the current developments in our understanding of these molecular and cellular events in remodeling and the various pharmacological, cellular and device therapies used to treat, and potentially retard, this condition. Specifically, this paper will examine the neurohormonal activity of the renin-angiotensin-aldosterone axis and its molecular effects on the heart. The emerging understanding of the extra-cellular matrix and the various active molecules within it, such as the matrix metalloproteinases, elicits new appreciation for their role in cardiac remodeling and as possible future therapeutic targets. Cell therapy with stem cells is another recent therapy with great potential in improving post-infarcted hearts. Lastly, the cellular and molecular effects of left ventricular assist devices on remodeling will be reviewed. Our increasing knowledge of the cellular and molecular mechanisms underlying cardiac remodeling enables us not only to better understand how our more successful therapies, like angiotensin-converting enzyme inhibitors, work, but also to explore new therapies of the future.

Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking.

Science.gov (United States)

Kozlowski, Allan J; Bryce, Thomas N; Dijkers, Marcel P

2015-01-01

Powered exoskeletons have been demonstrated as being safe for persons with spinal cord injury (SCI), but little is known about how users learn to manage these devices. To quantify the time and effort required by persons with SCI to learn to use an exoskeleton for assisted walking. A convenience sample was enrolled to learn to use the first-generation Ekso powered exoskeleton to walk. Participants were given up to 24 weekly sessions of instruction. Data were collected on assistance level, walking distance and speed, heart rate, perceived exertion, and adverse events. Time and effort was quantified by the number of sessions required for participants to stand up, walk for 30 minutes, and sit down, initially with minimal and subsequently with contact guard assistance. Of 22 enrolled participants, 9 screen-failed, and 7 had complete data. All of these 7 were men; 2 had tetraplegia and 5 had motor-complete injuries. Of these, 5 participants could stand, walk, and sit with contact guard or close supervision assistance, and 2 required minimal to moderate assistance. Walk times ranged from 28 to 94 minutes with average speeds ranging from 0.11 to 0.21 m/s. For all participants, heart rate changes and reported perceived exertion were consistent with light to moderate exercise. This study provides preliminary evidence that persons with neurological weakness due to SCI can learn to walk with little or no assistance and light to somewhat hard perceived exertion using a powered exoskeleton. Persons with different severities of injury, including those with motor complete C7 tetraplegia and motor incomplete C4 tetraplegia, may be able to learn to use this device.

Fluid removal in acute heart failure: diuretics versus devices.

Science.gov (United States)

Krishnamoorthy, Arun; Felker, G Michael

2014-10-01

Fluid removal and relief of congestion are central to treatment of acute heart failure. Diuretics have been the decongestive mainstay but their known limitations have led to the exploration of alternative strategies. This review compares diuretics with ultrafiltration and examines the recent evidence evaluating their use. Relevant recent studies are the Diuretic Optimization Strategies Evaluation trial (of diuretics) and the Cardiorenal Rescue Study in Acute Decompensated Heart Failure (of ultrafiltration). The Diuretic Optimization Strategies Evaluation study evaluated strategies of loop diuretic use during acute heart failure (continuous infusion versus intermittent bolus and high dose versus low dose). After 72  h, there was no significant difference with either comparison for the coprimary end points. Patients treated with a high-dose strategy tended to have greater diuresis and more decongestion compared with low-dose therapy, at the cost of transient changes in renal function. The Cardiorenal Rescue Study in Acute Decompensated Heart Failure study showed that in acute heart failure patients with persistent congestion and worsening renal function, ultrafiltration, as compared with a medical therapy, was associated with similar weight loss but greater increase in serum creatinine and more adverse events. Decongestion remains a major challenge in acute heart failure. Although recent studies provide useful data to guide practice, the relatively poor outcomes point to the continued need to identify better strategies for safe and effective decongestion.

Robot-Assisted Training Early After Cardiac Surgery.

Science.gov (United States)

Schoenrath, Felix; Markendorf, Susanne; Brauchlin, Andreas E; Seifert, Burkhardt; Wilhelm, Markus J; Czerny, Martin; Riener, Robert; Falk, Volkmar; Schmied, Christian M

2015-07-01

To assess feasibility and safety of a robot-assisted gait therapy with the Lokomat® system in patients early after open heart surgery. Within days after open heart surgery 10 patients were subjected to postoperative Lokomat® training (Intervention group, IG) whereas 20 patients served as controls undergoing standard postoperative physiotherapy (Control group, CG). All patients underwent six-minute walk test and evaluation of the muscular strength of the lower limbs by measuring quadriceps peak force. The primary safety end-point was freedom from any device-related wound healing disturbance. Patients underwent clinical follow-up after one month. Both training methods resulted in an improvement of walking distance (IG [median, interquartile range, p-value]: +119 m, 70-201 m, p = 0.005; CG: 105 m, 57-152.5m, p force (IG left: +5 N, 3.8 7 N, p = 0.005; IG right: +3.5 N, 1.5-8.8 N, p = 0.011; CG left: +5.5 N, 4-9 N, p training were comparable to early postoperative standard in hospital training (median changes in walking distance in percent, p = 0.81; median changes in quadriceps peak force in percent, left: p = 0.97, right p = 0.61). No deep sternal wound infection or any adverse event occurred in the robot-assisted training group. Robot-assisted gait therapy with the Lokomat® system is feasible and safe in patients early after median sternotomy. Results with robot-assisted training were comparable to standard in hospital training. An adapted and combined aerobic and resistance training intervention with augmented feedback may result in benefits in walking distance and lower limb muscle strength (ClinicalTrials.gov number, NCT 02146196). © 2015 Wiley Periodicals, Inc.

Overview of Robotic Devices for Nursing Care Project.

Science.gov (United States)

Hirukawa, Hirohisa

2017-01-01

METI/AMED are conducting a project on the development and deployment of robotic devices for nursing care to enhance the autonomy of elderly persons and assist care givers. An evaluation protocol is presented and the devices developed in the project are introduced. The devices consist of transfer assist devices (wearable/non-wearable), walking assist devices (outdoor/indoor), safety surveillance sensors (nursing home/private home), bath lift and toilet assist.

Future Prospects for the Total Artificial Heart.

Science.gov (United States)

Sunagawa, Gengo; Horvath, David J; Karimov, Jamshid H; Moazami, Nader; Fukamachi, Kiyotaka

2016-01-01

A total artificial heart (TAH) is the sole remaining option for patients with biventricular failure who cannot be rescued by left ventricular assist devices (LVADs) alone. However, the pulsatile TAH in clinical use today has limitations: large pump size, unknown durability, required complex anticoagulation regimen, and association with significant postsurgical complications. That pump is noisy; its large pneumatic driving lines traverse the body, with bulky external components for its drivers. Continuous-flow pumps, which caused a paradigm shift in the LVAD field, have already contributed to the rapidly evolving development of TAHs. Novel continuous-flow TAHs are only in preclinical testing or developmental stages. We here review the current state of TAHs, with recommended requirements for the TAH of the future.

An optimal controller for an electric ventricular-assist device: theory, implementation, and testing.

Science.gov (United States)

Klute, G K; Tasch, U; Geselowitz, D B

1992-04-01

This paper addresses the development and testing of an optimal position feedback controller for the Penn State electric ventricular-assist device (EVAD). The control law is designed to minimize the expected value of the EVAD's power consumption for a targeted patient population. The closed-loop control law is implemented on an Intel 8096 microprocessor and in vitro test runs show that this controller improves the EVAD's efficiency by 15-21%, when compared with the performance of the currently used feedforward control scheme.

The Heartmate III: design and in vivo studies of a maglev centrifugal left ventricular assist device.

Science.gov (United States)

Loree, H M; Bourque, K; Gernes, D B; Richardson, J S; Poirier, V L; Barletta, N; Fleischli, A; Foiera, G; Gempp, T M; Schoeb, R; Litwak, K N; Akimoto, T; Kameneva, M; Watach, M J; Litwak, P

2001-05-01

A compact implantable centrifugal left ventricular assist device (LVAD) (HeartMate III) featuring a magnetically levitated impeller is under development. The goal of our ongoing work is to demonstrate feasibility, low hemolysis, and low thrombogenicity of the titanium pump in chronic bovine in vivo studies. The LVAD is based on so-called bearingless motor technology and combines pump rotor, drive, and magnetic bearing functions in a single unit. The impeller is rotated (theta z) and levitated with both active (X, Y) and passive (Z, theta x, theta y) suspension. Six prototype systems have been built featuring an implantable titanium pump (69 mm diameter, 30 mm height) with textured blood contacting surfaces and extracorporeal electronics. The pumps were implanted in 9 calves (< or = 100 kg at implant) that were anticoagulated with Coumadin (2.5 < or = INR < or = 4.0) throughout the studies. Six studies were electively terminated (at 27-61 days), 1 study was terminated after the development of severe pneumonia and lung atelectasis (at 27 days) another study was terminated after cardiac arrest (at 2 days) while a final study is ongoing (at approximately 100 days). Mean pump flows ranged from 2 to 7 L/min, except for brief periods of exercise at 6 to 9 L/min. Plasma free hemoglobin ranged from 4 to 10 mg/dl. All measured biochemical indicators of end organ function remained within normal range. The pumps have met performance requirements in all 9 implants with acceptable hemolysis and no mechanical failures.

An accelerometry-based comparison of 2 robotic assistive devices for treadmill training of gait.

Science.gov (United States)

Regnaux, Jean-Philippe; Saremi, Kaveh; Marehbian, Jon; Bussel, Bernard; Dobkin, Bruce H

2008-01-01

Two commercial robotic devices, the Gait Trainer (GT) and the Lokomat (LOKO), assist task-oriented practice of walking. The gait patterns induced by these motor-driven devices have not been characterized and compared. A healthy participant chose the most comfortable gait pattern on each device and for treadmill (TM) walking at 1, 2 (maximum for the GT), and 3 km/h and over ground at similar speeds. A system of accelerometers on the thighs and feet allowed the calculation of spatiotemporal features and accelerations during the gait cycle. At the 1 and 2 km/h speed settings, single-limb stance times were prolonged on the devices compared with overground walking. Differences on the LOKO were decreased by adjusting the hip and knee angles and step length. At the 3 km/h setting, the LOKO approximated the participant's overground parameters. Irregular accelerations and decelerations from toe-off to heel contact were induced by the devices, especially at slower speeds. The LOKO and GT impose mechanical constraints that may alter leg accelerations-decelerations during stance and swing phases, as well as stance duration, especially at their slower speed settings, that are not found during TM and overground walking. The potential impact of these perturbations on training to improve gait needs further study.

Costs and reimbursement gaps after implementation of third-generation left ventricular assist devices.

Science.gov (United States)

Mishra, Vinod; Geiran, Odd; Fiane, Arnt E; Sørensen, Gro; Andresen, Sølvi; Olsen, Ellen K; Khushi, Ishtiaq; Hagen, Terje P

2010-01-01

The purpose of this study was to compare and contrast total hospital costs and subsequent reimbursement of implementing a new program using a third-generation left ventricular assist device (LVAD) in Norway. Between July 2005 and March 2008, the total costs of treatment for 9 patients were examined. Costs were calculated for three periods-the pre-implantation LVAD phase, the LVAD implantation phase and the post-implantation LVAD phase-as well as for total hospital care. Patient-specific costs were obtained prospectively from patient records and included personnel resources, medication, blood products, blood chemistry and microbiology, imaging, and procedure costs including operating room costs. Overhead costs were registered retrospectively and allocated to the specific patient by pre-defined allocation keys. Finally, patient-specific costs and overhead costs were aggregated into total patient costs. The average total patient cost in 2007 U.S. dollars was $735,342 and the median was $613,087 (range $342,581 to $1,256,026). The mean length of stay was 77 days (range 40 to 127 days). For the LVAD implantation phase, the mean cost was $457,795 and median cost was $458,611 (range $246,239 to $677,680). The mean length of stay for the LVAD implantation phase was 55 days (range 25 to 125 days). The diagnosis-related group (DRG) reimbursement (2007) was $143,192. There is significant discrepancy between actual hospital costs and the current Norwegian DRG reimbursement for the LVAD procedure. This discrepancy can be partly explained by excessive costs related to the introduction of a new program with new technology. Costly innovations should be considered in price setting of reimbursement for novel technology. Copyright (c) 2010 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Developments in mechanical heart valve prosthesis

Indian Academy of Sciences (India)

Artificial heart valves are engineered devices used for replacing diseased or damaged natural valves of the heart. Most commonly used for replacement are mechanical heart valves and biological valves. This paper briefly outlines the evolution, designs employed, materials being used,. and important factors that affect the ...

Self-Organizing Wearable Device Platform for Assisting and Reminding Humans in Real Time

Directory of Open Access Journals (Sweden)

Yu Jin Park

2016-01-01

Full Text Available Most older persons would prefer “aging in my place,” that is, to remain in good health and live independently in their own home as long as possible. For assisting the independent living of older people, the ability to gather and analyze a user’s daily activity data would constitute a significant technical advance, enhancing their quality of life. However, the general approach based on centralized server has several problems such as the usage complexity, the high price of deployment and expansion, and the difficulty in identifying an individual person. To address these problems, we propose a wearable device platform for the life assistance of older persons that automatically records and analyzes their daily activity without intentional human intervention or a centralized server (i.e., cloud server. The proposed platform contains self-organizing protocols, Delay-Tolerant Messaging system, knowledge-based analysis and alerting for daily activities, and a hardware platform that provides low power consumption. We implemented a prototype smart watch, called Personal Activity Assisting and Reminding (PAAR, as a testbed for the proposed platform, and evaluated the power consumption and the service time of example scenarios.

Reference Device-Assisted Adaptive Location Fingerprinting

Directory of Open Access Journals (Sweden)

Dongjin Wu

2016-06-01

Full Text Available Location fingerprinting suffers in dynamic environments and needs recalibration from time to time to maintain system performance. This paper proposes an adaptive approach for location fingerprinting. Based on real-time received signal strength indicator (RSSI samples measured by a group of reference devices, the approach applies a modified Universal Kriging (UK interpolant to estimate adaptive temporal and environmental radio maps. The modified UK can take the spatial distribution characteristics of RSSI into account. In addition, the issue of device heterogeneity caused by multiple reference devices is further addressed. To compensate the measuring differences of heterogeneous reference devices, differential RSSI metric is employed. Extensive experiments were conducted in an indoor field and the results demonstrate that the proposed approach not only adapts to dynamic environments and the situation of changing APs’ positions, but it is also robust toward measuring differences of heterogeneous reference devices.

Design and principle of operation of the HeartMate PHP (percutaneous heart pump).

Science.gov (United States)

Van Mieghem, Nicolas M; Daemen, Joost; den Uil, Corstiaan; Dur, Onur; Joziasse, Linda; Maugenest, Anne-Marie; Fitzgerald, Keif; Parker, Chris; Muller, Paul; van Geuns, Robert-Jan

2018-02-20

The HeartMate PHP (percutaneous heart pump) is a second-generation transcatheter axial flow circulatory support system. The collapsible catheter pump is inserted through a 14 Fr sheath, deployed across the aortic valve expanding to 24 Fr and able to deliver up to 5 L/min blood flow at minimum haemolytic risk. As such, this device may be a valuable adjunct to percutaneous coronary intervention (PCI) of challenging lesions in high-risk patients or treatment of cardiogenic shock. This technical report discusses: (i) the HeartMate PHP concept, (ii) the implantation technique, (iii) the haemodynamic performance in an in vitro cardiovascular flow testing set-up, and (iv) preliminary clinical experience. An update on the device, produced by St. Jude Medical/Abbott Laboratories, can be found in the Appendix.

Designs for mechanical circulatory support device studies.

Science.gov (United States)

Neaton, James D; Normand, Sharon-Lise; Gelijns, Annetine; Starling, Randall C; Mann, Douglas L; Konstam, Marvin A

2007-02-01

There is increased interest in mechanical circulatory support devices (MCSDs), such as implantable left ventricular assist devices (LVADs), as "destination" therapy for patients with advanced heart failure. Because patient availability to evaluate these devices is limited and randomized trials have been slow in enrolling patients, a workshop was convened to consider designs for MCSD development including alternatives to randomized trials. A workshop was jointly planned by the Heart Failure Society of America and the US Food and Drug Administration and was convened in March 2006. One of the panels was asked to review different designs for evaluating new MCSDs. Randomized trials have many advantages over studies with no controls or with nonrandomized concurrent or historical controls. These advantages include the elimination of bias in the assignment of treatments and the balancing, on average, of known and unknown baseline covariates that influence response. These advantages of randomization are particularly important for studies in which the treatments may not differ from one another by a large amount (eg, a head-to-head study of an approved LVAD with a new LVAD). However, researchers have found it difficult to recruit patients to randomized studies because the number of clinical sites that can carry out the studies is not large. Also, there is a reluctance to randomize patients when the control device is considered technologically inferior. Thus ways of improving the design of randomized trials were discussed, and the advantages and disadvantages of alternative designs were considered. The panel concluded that designs should include a randomized component. Randomized designs might be improved by allowing the control device to be chosen before randomization, by first conducting smaller vanguard studies, and by allowing crossovers in trials with optimal medical management controls. With use of data from completed trials, other databases, and registries, alternative

"Pseudo" Faraday cage: a solution for telemetry link interaction between a left ventricular assist device and an implantable cardioverter defibrillator.

Science.gov (United States)

Jacob, Sony; Cherian, Prasad K; Ghumman, Waqas S; Das, Mithilesh K

2010-09-01

Patients implanted with left ventricular assist devices (LVAD) may have implantable cardioverter defibrillators (ICD) implanted for sudden cardiac death prevention. This opens the possibility of device-device communication interactions and thus interferences. We present a case of such interaction that led to ICD communication failure following the activation of an LVAD. In this paper, we describe a practical solution to circumvent the communication interference and review the communication links of ICDs and possible mechanisms of ICD-LVAD interactions.

Y stenting assisted coiling using a new low profile visible intraluminal support device for wide necked basilar tip aneurysms: a technical report.

Science.gov (United States)

Conrad, Marcelo D; Brasiliense, Leonardo B C; Richie, Alexa N; Hanel, Ricardo A

2014-05-01

Many endovascular techniques have been described in recent years for the management of wide necked aneurysms. The Y stent assisted technique has been generally used for coil embolization of wide necked bifurcation aneurysms. This technique was first described for the treatment of basilar tip aneurysms in combination with several different devices, demonstrating encouraging results. We report the results of the first two cases of wide necked basilar tip aneurysms treated with Y stent assisted coil embolization using a new low profile visible intraluminal stent (LVIS Jr; MicroVention, Tustin, California, USA) delivered through a 0.017 inch microcatheter. We also reviewed the literature comparing other endovascular techniques (coiling alone, stent assisted coiling, and Y stent assisted coiling) for wide necked aneurysms. The LVIS Jr device offers a new option for the treatment of these challenging lesions, with clear advantages over currently available intracranial stents. Larger series and long term results are needed to confirm the applicability and durability of this technique/technology.

Rapid prototyping of 2D glass microfluidic devices based on femtosecond laser assisted selective etching process

Science.gov (United States)

Kim, Sung-Il; Kim, Jeongtae; Koo, Chiwan; Joung, Yeun-Ho; Choi, Jiyeon

2018-02-01

Microfluidics technology which deals with small liquid samples and reagents within micro-scale channels has been widely applied in various aspects of biological, chemical, and life-scientific research. For fabricating microfluidic devices, a silicon-based polymer, PDMS (Polydimethylsiloxane), is widely used in soft lithography, but it has several drawbacks for microfluidic applications. Glass has many advantages over PDMS due to its excellent optical, chemical, and mechanical properties. However, difficulties in fabrication of glass microfluidic devices that requires multiple skilled steps such as MEMS technology taking several hours to days, impedes broad application of glass based devices. Here, we demonstrate a rapid and optical prototyping of a glass microfluidic device by using femtosecond laser assisted selective etching (LASE) and femtosecond laser welding. A microfluidic droplet generator was fabricated as a demonstration of a microfluidic device using our proposed prototyping. The fabrication time of a single glass chip containing few centimeter long and complex-shaped microfluidic channels was drastically reduced in an hour with the proposed laser based rapid and simple glass micromachining and hermetic packaging technique.

A durability study of a paracorporeal pulsatile electro-mechanical pneumatic biventricular assist device.

Science.gov (United States)

Choi, Hyuk; Lee, Heung-Man; Nam, Kyoung Won; Choi, Jaesoon; Lee, Jung-Joo; Kim, Ho Chul; Song, Seung Joon; Ahn, Chi Bum; Son, Ho Sung; Lim, Choon Hak; Son, Kuk Hui; Park, Yong Doo; Jeong, Gi Seok; Sun, Kyung

2011-06-01

In 2002, the paracorporeal pulsatile electro-mechanical pneumatic ventricular assist device (VAD) began to be developed by the Korea Artificial Organ Center at Korea University under a Health & Medical Technology Research and Development program which finished in 2008. In vitro durability testing was conducted on the paracorporeal pulsatile pneumatic VAD to determine device durability and to evaluate device failures. The 1- and 2-year reliability of the paracorporeal pulsatile pneumatic VAD was shown to be 91.2% and 54.9%, respectively, with an 80% confidence level. Failure modes were analyzed using fault tree analysis, with customized software continuously acquiring data during the test period. After this period, 21 in vivo animal tests were done, with 14 cases of left atrium to left ventricle (LV) inflow cannulation (36Fr)/outflow grafting to descending aorta, and seven cases of apex cannulation of LV to descending aorta (12 mm). The longest postoperative day (182 days) in Korea was recently recorded in in vivo animal testing (bovine, 90 kg, male, 3.5-4.0 L/min flow rate, and 55 bpm). © 2011, Copyright the Authors. Artificial Organs © 2011, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Cross-cultural adaptation of the psychosocial impact of assistive device scale (PIADS) for Puerto Rican assistive technology users.

Science.gov (United States)

Orellano, Elsa M; Jutai, Jeffrey W

2013-01-01

Assistive technology (AT) is important for individuals with disabilities' independence and participation in daily life, and there is a lack of valid AT outcome tools for the Puerto Rican population. This pilot study examined the content validity of a new adaptation of the Psychosocial Impact of Assistive Device Scale (PIADS): the Puerto Rican-Spanish PIADS (PR-PIADS). Following standard procedures, the cultural adaptation methodology included a bilingual multidisciplinary committee review of the original (English language) and Spanish versions of the PIADS and pilot testing of the preliminary version of the PR-PIADS with 20 AT users. The committee recommended a total of 58 semantic and conceptual modifications of the Spanish PIADS. Pilot data analysis resulted in 4 additional semantic and conceptual modifications of items that did not reach the minimum content validity ratio of 0.42 for a panel composed by 20 members: competence (0), efficiency (-0.6), performance (-0.95), and eagerness to take chances (-0.6). This pilot study demonstrated evidence of initial content validity of the PR-PIADS. Future research is required before using this tool with greater confidence to address the construct validity and reliability that are also critical to a successful cultural adaptation.

Decision making for destination therapy left ventricular assist devices: "there was no choice" versus "I thought about it an awful lot".

Science.gov (United States)

McIlvennan, Colleen K; Allen, Larry A; Nowels, Carolyn; Brieke, Andreas; Cleveland, Joseph C; Matlock, Daniel D

2014-05-01

Destination therapy left ventricular assist devices (DT LVADs) are one of the most invasive medical interventions for end-stage illness. How patients decide whether or not to proceed with device implantation is unknown. We aimed to understand the decision-making processes of patients who either accept or decline DT LVADs. Between October 2012 and September 2013, we conducted semistructured, in-depth interviews to understand patients' decision-making experiences. Data were analyzed using a mixed inductive and deductive approach. Twenty-two eligible patients were interviewed, 15 with DT LVADs and 7 who declined. We found a strong dichotomy between decision processes with some patients (11 accepters) being automatic and others (3 accepters, 7 decliners) being reflective in their approach to decision making. The automatic group was characterized by a fear of dying and an over-riding desire to live as long as possible: "[LVAD] was the only option I had…that or push up daisies…so I automatically took this." By contrast, the reflective group went through a reasoned process of weighing risks, benefits, and burdens: "There are worse things than death." Irrespective of approach, most patients experienced the DT LVAD decision as a highly emotional process and many sought support from their families or spiritually. Some patients offered a DT LVAD face the decision by reflecting on a process and reasoning through risks and benefits. For others, the desire to live supersedes such reflective processing. Acknowledging this difference is important when considering how to support patients who are faced with this complex decision. © 2014 American Heart Association, Inc.

Control system for an artificial heart

Science.gov (United States)

Gebben, V. D.; Webb, J. A., Jr.

1970-01-01

Inexpensive industrial pneumatic components are combined to produce control system to drive sac-type heart-assistance blood pump with controlled pulsatile pressure that makes pump rate of flow sensitive to venous /atrial/ pressure, while stroke is centered about set operating point and pump is synchronized with natural heart.

Validation of a laser-assisted wound measurement device in a wound healing model.

Science.gov (United States)

Constantine, Ryan S; Bills, Jessica D; Lavery, Lawrence A; Davis, Kathryn E

2016-10-01

In the treatment and monitoring of a diabetic or chronic wound, accurate and repeatable measurement of the wound provides indispensable data for the patient's medical record. This study aims to measure the accuracy of the laser-assisted wound measurement (LAWM) device against traditional methods in the measurement of area, depth and volume. We measured four 'healing' wounds in a Play-Doh(®) -based model over five subsequent states of wound healing progression in which the model was irregularly filled in to replicate the healing process. We evaluated the LAWM device against traditional methods including digital photograph assessment with National Institutes of Health ImageJ software, measurements of depth with a ruler and weight-to-volume assessment with dental paste. Statistical analyses included analysis of variance (ANOVA) and paired t-tests. We demonstrate that there are significantly different and nearly statistically significant differences between traditional ruler depth measurement and LAWM device measurement, but there are no statistically significant differences in area measurement. Volume measurements were found to be significantly different in two of the wounds. Rate of percentage change was analysed for volume and depth in the wound healing model, and the LAWM device was not significantly different than the traditional measurement technique. While occasionally inaccurate in its absolute measurement, the LAWM device is a useful tool in the clinician's arsenal as it reliably measures rate of percentage change in depth and volume and offers a potentially aseptic alternative to traditional measurement techniques. © 2014 The Authors. International Wound Journal © 2014 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Clinical and hemodynamic effects of intra-aortic balloon pump therapy in chronic heart failure patients with cardiogenic shock.

Science.gov (United States)

Fried, Justin A; Nair, Abhinav; Takeda, Koji; Clerkin, Kevin; Topkara, Veli K; Masoumi, Amirali; Yuzefpolskaya, Melana; Takayama, Hiroo; Naka, Yoshifumi; Burkhoff, Daniel; Kirtane, Ajay; Dimitrios Karmpaliotis, S M; Moses, Jeffrey; Colombo, Paolo C; Garan, A Reshad

2018-03-20

The role of the intra-aortic balloon pump (IABP) in acute decompensated heart failure (HF) with cardiogenic shock (CS) is largely undefined. In this study we sought to assess the hemodynamic and clinical response to IABP in chronic HF patients with CS and identify predictors of response to this device. We retrospectively reviewed all patients undergoing IABP implantation from 2011 to 2016 at our institution to identify chronic HF patients with acute decompensation and CS (cardiac index <2.2 liters/min/m 2 and systolic blood pressure <90 mm Hg or need for vasoactive medications to maintain this level). Clinical deterioration on IABP was defined as failure to bridge to either discharge on medical therapy or durable heart replacement therapy (HRT; durable left ventricular assist device or heart transplant) with IABP alone. We identified 132 chronic HF patients with IABP placed after decompensation with hemodynamic evidence of CS. Overall 30-day survival was 84.1%, and 78.0% of patients were successfully bridged to HRT or discharge without need for escalation of device support. The complication rate during IABP support was 2.3%. Multivariable analysis identified ischemic cardiomyopathy (odds ratio [OR] 3.24, 95% confidence interval [CI] 1.16 to 9.06; p = 0.03) and pulmonary artery pulsatility index (PAPi) <2.0 (OR 5.04, 95% CI 1.86 to 13.63; p = 0.001) as predictors of clinical deterioration on IABP. Overall outcomes with IABP in acute decompensated chronic HF patients are encouraging, and IABP is a reasonable first-line device for chronic HF patients with CS. Baseline right ventricular function, as measured by PAPi, is a major predictor of outcomes with IABP in this population. Copyright © 2018 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

[Total artificial heart].

Science.gov (United States)

Antretter, H; Dumfarth, J; Höfer, D

2015-09-01

To date the CardioWest™ total artificial heart is the only clinically available implantable biventricular mechanical replacement for irreversible cardiac failure. This article presents the indications, contraindications, implantation procedere and postoperative treatment. In addition to a overview of the applications of the total artificial heart this article gives a brief presentation of the two patients treated in our department with the CardioWest™. The clinical course, postoperative rehabilitation, device-related complications and control mechanisms are presented. The total artificial heart is a reliable implant for treating critically ill patients with irreversible cardiogenic shock. A bridge to transplantation is feasible with excellent results.

Towards robot-assisted anchor deployment in beating-heart mitral valve surgery.

Science.gov (United States)

Cheng, Lingbo; Sharifi, Mojtaba; Tavakoli, Mahdi

2018-06-01

Beating-heart intracardiac surgery promises significant benefits for patients compared with cardiopulmonary bypass based procedures. However, the fast motions of the heart introduce serious challenges for surgeons. In this work, a new impedance-controlled master-slave telerobotic system is developed to help perform anchor deployment for mitral valve annuloplasty under the guidance of live ultrasound images of the heart. The proposed bilateral teleoperation system can both reflect the non-oscillatory portion of slave-heart tissue interaction force on the surgeon's hand as haptic feedback and implement rapid compensation for the beating heart's motion. The surgical task involves performing anchor deployment on a simulated moving heart tissue to evaluate the effectiveness of the proposed strategy for safely interacting with a moving organ. The results obtained show that the telerobotic system increases the success rate of anchor deployment by 100% and reduces the excess force application rate by 70% compared with manual attempts. Copyright © 2018 John Wiley & Sons, Ltd.

Overview of Heart Tumors

Science.gov (United States)

... Tumors By Siddique A. Abbasi, MD, MSc, Assistant Professor of Medicine, Warren Alpert Medical School of Brown University; Attending Cardiologist, Director of Heart Failure, and Director of Cardiac MRI, Providence VA Medical ...

Detection of premature ventricular contractions on a ventricular electrocardiogram for patients with left ventricular assist devices.

Science.gov (United States)

Park, Sung Min; Lee, Jin Hong; Choi, Seong Wook

2014-12-01

The ventricular electrocardiogram (v-ECG) was developed for long-term monitoring of heartbeats in patients with a left ventricular assist device (LVAD) and does not normally have the functionality necessary to detect additional heart irregularities that can progress to critical arrhythmias. Although the v-ECG has the benefits of physiological optimization and counterpulsation control, when abnormal heartbeats occur, the v-ECG does not show the distinct abnormal waveform that enables easy detection of an abnormal heartbeat among normal heartbeats on the conventional ECG. In this study, the v-ECGs of normal and abnormal heartbeats are compared with each other with respect to peak-to-peak voltage, area, and maximal slopes, and a new method to detect abnormal heartbeats is suggested. In a series of animal experiments with three porcine models (Yorkshire pigs weighing 30-40 kg), a v-ECG and conventional ECG were taken simultaneously during LVAD perfusion. Clinical experts found 104 abnormal heartbeats from the saved conventional ECG data and confirmed that the other 3159 heartbeats were normal. Almost all of the abnormal heartbeats were premature ventricular contractions (PVCs), and there was short-term tachycardia for 3 s. A personal computer was used to automatically detect abnormal heartbeats with the v-ECG according to the new method, and its results were compared with the clinicians' results. The new method found abnormal heartbeats with 90% accuracy, and less than 15% of the total PVCs were missed. Copyright © 2014 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.